For FDA approval, a South Korean manufacturer usually needs 510(k) clearance, which FDA decides on your evidence rather than your MFDS licence, and many devices need no 510(k) at all. Every device still needs establishment registration, device listing and a US Agent before it is imported or sold in the US.
Key takeaways
- FDA cleared 695 510(k)s from Korean applicants from January 2023 to September 2026. Only the US and China had more. Half were dental or radiology devices.
- An MFDS licence does not replace or shorten a 510(k). Your test reports and quality system can carry over. The licence itself does not.
- Of 788 Korean sites registered with FDA as device manufacturers, 387 list no device with a 510(k) or PMA number. Many devices are exempt, but Class I does not always mean exempt.
- Korean Traditional 510(k)s took a median of 175.5 days from receipt to clearance, about 9% longer than typical for the same device types. Special 510(k)s took a median of 30 days.
- The FY2027 510(k) fee is $28,653, or $7,163 for a small business. A Korean company qualifies with a certification from its national tax authority.
How many Korean devices does FDA clear, and which kinds?
We counted every 510(k) that FDA cleared from January 3, 2023 to September 27, 2026, using FDA's public 510(k) data [1]. Applicants in South Korea received 695 clearances. That is 5.8% of all 12,058 clearances, and the third most of any country after the US (5,840) and China (1,997). Germany was fourth with 420.
The 695 clearances went to 281 companies. The count fell from 218 in 2023 to 156 in 2025. But 2026 is running ahead of 2025: 131 clearances to the end of September, against 121 in the same months of 2025 [1].
Korean clearances are concentrated in a few fields [1]:
| FDA review panel | Korean clearances | Share |
|---|---|---|
| Dental | 193 | 28% |
| Radiology | 155 | 22% |
| General and plastic surgery | 130 | 19% |
| Orthopedic | 83 | 12% |
| Gastroenterology and urology | 28 | 4% |
| Neurology | 23 | 3% |
| All others | 83 | 12% |
These are the most common device types. FDA calls each type a product code [1]:
| Device type (product code) | Korean clearances |
|---|---|
| Electrosurgical cutting and coagulation devices (GEI) | 51 |
| Dental implant abutments (NHA) | 44 |
| Root-form dental implants (DZE) | 42 |
| Powered laser surgical instruments (GEX) | 39 |
| Radiological image processing systems (LLZ) | 23 |
| Automated radiological image processing software (QIH) | 23 |
| Doppler ultrasound imaging systems (IYN) | 16 |
| Tooth shade resin materials (EBF) | 15 |
Radiology software is a growing share. Korean companies received 23 clearances for automated radiological image processing software (QIH). Our AI device tracker covers AI-enabled devices across all countries.
Our method: we counted cleared decisions where the applicant's address is in South Korea. The applicant is usually the manufacturer. A Korean company that files through a US subsidiary is counted under the US.
Does an MFDS licence help with FDA clearance?
Not directly. FDA does not accept an MFDS licence in place of a 510(k). The 510(k) rules apply to every company that must register with FDA, wherever it is [4]. FDA makes its own decision on your evidence.
What can carry over is the evidence behind your licence:
- Test reports. FDA accepts reports from Korean labs if they meet its expectations, such as testing to the FDA-recognized version of each standard. The section on test reports below covers this.
- Your quality system. FDA's Quality Management System Regulation took effect on February 2, 2026. It incorporates ISO 13485:2016 by reference [9]. A working ISO 13485 system is a strong base. But FDA says it will not accept an ISO 13485 certificate as a substitute for its own oversight, including inspections [9].
- Clinical data, if you need it. Most 510(k)s include no clinical data. Our analysis of when a 510(k) needs clinical data shows how often they do. FDA can accept data from a Korean clinical study if it followed good clinical practice and you provide the required supporting information [4].
- MDSAP audits. MFDS is an Affiliate Member of the Medical Device Single Audit Program [8]. That status does not change your 510(k). But FDA may accept an MDSAP audit report in place of a routine FDA inspection [8].
What does not carry over is your comparison device. A 510(k) must compare your device to a predicate that is legally marketed in the US [4]. A device sold only in Korea cannot be your predicate. For the full picture, see our guide to what an MFDS licence does and does not change.
Does every Korean device need a 510(k)?
No. This is a common misconception. Each device type has a classification regulation, and it says whether a 510(k) is needed. Most Class I types and some Class II types are exempt [11].
FDA's registration data shows how often this applies. On October 12, 2026, 889 Korean sites were registered with FDA. Of the 788 registered as device manufacturers, 387 (49%) list no device with a 510(k) or PMA number. For 290 of them, every listed device is Class I [2].
Two cautions:
- Class I does not always mean exempt. Patient examination gloves are Class I, and they still need a 510(k) [11].
- Exemptions have limits. An exempt device still needs a 510(k) if, for example, it has a different intended use or uses a different fundamental scientific technology from other devices of its type. Each classification part sets out these limits, such as 21 CFR 880.9 for hospital devices [4].
Exempt devices still need establishment registration, device listing and a US Agent before they are imported [4]. Check your device's product code in FDA's classification database before you plan a 510(k) [11]. Our device classification guide explains how to read an entry.
What are the steps from Korea to the US market?
For a device that needs a 510(k), the usual order is:
- Confirm the classification. Find the product code, regulation number and class. If you cannot tell, you can ask FDA through a 513(g) request. Its FY2027 fee is $8,596, or $4,298 for a small business [3].
- Choose a predicate. Pick a device legally marketed in the US with the same intended use. Search FDA's 510(k) database by product code. Our predicate guide explains how.
- Plan and run the testing. Test to the FDA-recognized version of each standard, at a lab in Korea or elsewhere.
- Request small business status early. If your company and its affiliates had gross receipts of no more than $100 million, apply at least 60 days before the 510(k) fee is due [3].
- Build the submission in eSTAR. FDA has required eSTAR for 510(k)s since October 1, 2023 [5]. All content must be in English, including translated test reports [6].
- Pay the fee and submit. FDA must receive the correct fee when you submit, or it will not accept the 510(k) [3]. FDA then has 15 calendar days for its acceptance review [6].
- Answer FDA's questions. If FDA sends an Additional Information request, the review goes on hold. You have up to 180 calendar days to send a complete response, or FDA considers the 510(k) withdrawn [7].
- Receive the clearance letter. Your device is cleared, not approved. Approval is the word for PMA devices.
- Register, list and name a US Agent. Do this before the device is imported. The sections below cover timing and cost, and our importing guide covers customs entry.
Your team runs the testing through labs of your choice. A US Agent and an importer fill the US roles, and you can add a regulatory advisor.
What does FDA clearance cost a Korean manufacturer?
FDA's fees for fiscal year 2027 apply from October 1, 2026 to September 30, 2027 [3]:
| FDA fee (FY2027) | Standard | Small business |
|---|---|---|
| 510(k) | $28,653 | $7,163 |
| 513(g) request for classification | $8,596 | $4,298 |
| De Novo request | $191,020 | $47,755 |
| Annual establishment registration | $13,785 | $13,785 |
The small business rate cuts the 510(k) fee by three quarters. To get it, a company outside the US sends FDA a MDUFA Small Business Request form and a certification from its national tax authority. For a Korean company, that is the National Tax Service. The certification must show gross receipts for the most recent tax year in both US dollars and Korean won, the exchange rate used and the dates covered. Each affiliate needs its own certification [3].
Small business status lasts one fiscal year. Status for FY2026 ended on September 30, 2026, so you must qualify again for FY2027 [3]. Our small business guide walks through the request.
The annual registration fee has no small business rate. FDA may waive it only for a business with no more than $1 million in gross receipts on its most recent US federal tax return [3].
FDA fees are only part of the budget. The real cost drivers are:
- Testing. Its scope depends on your device type and predicate.
- Translation. Every report and supporting document must be in English [6].
- Repeat work. Tests to the wrong standard version, or a weak response to FDA's questions, add cost and time.
- US roles. You will pay a US Agent, and you may pay an advisor.
Use our FDA user fees page to check the current rates before you budget.
How long does FDA clearance take for Korean manufacturers?
Korean Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 175.5 days from FDA's receipt to clearance. A quarter cleared within 94 days, and a quarter took 264 days or more [1]. The median for all applicants was 151 days.
Part of the gap is the device mix. Compared with the median for the same device types, Korean 510(k)s took about 9% longer [1]. Device type matters a lot [1]:
| Device type (product code) | Korean median (days) | All applicants median (days) |
|---|---|---|
| Powered laser surgical instruments (GEX) | 98.5 | 94 |
| Doppler ultrasound imaging systems (IYN) | 101.5 | 121 |
| Dental implant abutments (NHA) | 148 | 149 |
| Radiological image processing systems (LLZ) | 151.5 | 157 |
| Automated radiological image processing software (QIH) | 200 | 154 |
| Bone fixation plates (HRS) | 209.5 | 98 |
| Electrosurgical devices (GEI) | 215.5 | 140 |
| Root-form dental implants (DZE) | 238 | 218 |
The all-applicant figures include the Korean clearances. Each Korean figure covers at least 10 Traditional clearances.
FDA's review goal counts only FDA's own days. Its clock stops while it waits for your answers, and it starts only once FDA accepts the file [7]. So much of a long total is time on hold. That puts the fastest lever in your hands: a complete eSTAR and quick, complete answers to FDA's questions. Our review times by country analysis has the full method.
Two routes were faster. Special 510(k)s, used for changes to your own cleared device, took a median of 30 days. Korean companies used them for 113 of 695 clearances (16%). Only 17 Korean clearances (2.4%) used third-party review [1]. Check whether your device type is eligible, using our third-party review guide.
When do you need a US Agent and FDA registration?
Not before your 510(k). You can submit a 510(k) and receive clearance before you register. But no device may be imported into the US unless its maker's site is registered and the device is listed [4].
The rules for a Korean site [4]:
- Timing. Register within 30 days of starting the operation that requires registration, and list your devices at the same time.
- Fee first. Pay the annual registration fee before you register. A site is not legally registered until it has registered and paid [3].
- One US Agent. Name one US Agent who lives or has a place of business in the US. FDA may contact the agent when it cannot reach you, and the agent helps schedule inspections. Report any change to the agent within 10 business days.
- Every year. Renew registration and review all listings between October 1 and December 31.
- English. Registration and listing information must be in English.
X-ray and laser devices have extra rules. About 1 in 6 Korean clearances (117 of 695) were X-ray equipment or lasers [1]. These are also radiation-emitting electronic products. X-ray systems and many laser products need a radiation safety product report, which must reach FDA before the product enters commerce [4]. A maker of electronic products must also name a permanent US resident, a person or a company, as its agent for legal notices before offering a product for import. This is a separate designation from the US Agent in your registration [4]. MDSAP audits do not replace FDA inspections for these radiation rules [8].
Complizen's US team handles establishment registration, device listing and the US Agent role for foreign manufacturers. Exempt devices can enter the US this way while a 510(k) for another device is still in progress.
Which Korean test reports does FDA accept?
FDA accepts test reports from Korean labs. What counts is the standard and version you tested to, the completeness of the report and how the study was run, not where the lab is.
Three points matter most for Korean manufacturers:
- ASCA labs. On October 12, 2026, FDA's ASCA program listed two accredited labs in South Korea: CSA Group Korea and HCT Co., Ltd. Both are accredited for basic safety and essential performance testing [10]. Neither covers biocompatibility.
- Lab accreditation is not GLP. For biocompatibility, FDA recommends complete test reports and a statement that the studies followed its Good Laboratory Practice rules in 21 CFR Part 58 [12]. ISO/IEC 17025 accreditation, from KOLAS or any other body, does not answer that. FDA notes it does not recognize ISO/IEC 17025 for this purpose [12].
- Translations. Translate every report into English, including the test method and results [6].
Our guide to using foreign test reports in a 510(k) covers the full rules.
What do Korean manufacturers get wrong?
Each of these mistakes breaks a clear FDA rule:
| Common mistake | What FDA actually requires |
|---|---|
| Sending the MFDS technical file as the 510(k) | A comparison to a US predicate, in the eSTAR format, in English [4, 5, 6] |
| Choosing a predicate sold only in Korea | A predicate legally marketed in the US [4] |
| Testing to a standard version FDA no longer recognizes | The FDA-recognized version, checked before testing starts |
| Paying the full 510(k) fee by mistake | A small business request, with a National Tax Service certification, at least 60 days before paying [3] |
| Assuming every Class I device is exempt | A check of each product code: exam gloves are Class I and need a 510(k) [11] |
| Missing the radiation rules for X-ray and laser devices | A product report before sale, and an agent for legal notices before import [4] |
| Answering an FDA question late or in part | A complete response within 180 calendar days, or the 510(k) is withdrawn [7] |
What should you do next?
Start with your product code. It tells you whether you need a 510(k), which standards apply and how long similar devices have taken. Then compare your MFDS file with what a 510(k) for that product code needs. Before you submit, decide who will answer FDA's questions in English, and how fast. Holds are where much of the time goes.
If you want a second view of that comparison, Complizen's free Gap Assessment checks your device documents against what a 510(k) needs before you file. For the wider picture of selling in the US from outside it, see our international path.
Frequently asked questions
How does a South Korean manufacturer get FDA approval?
Most devices from South Korea need 510(k) clearance, not approval. You show that your device is substantially equivalent to a predicate legally marketed in the US. Some devices are exempt from a 510(k). Every device also needs FDA establishment registration, device listing and a US Agent before import.
Does an MFDS licence speed up FDA clearance?
No. FDA does not accept an MFDS licence in place of a 510(k), and it does not shorten FDA's review. What can carry over is the evidence behind the licence, such as test reports to FDA-recognized standards and an ISO 13485 quality system. FDA judges that evidence on its own terms.
How many Korean medical devices has FDA cleared?
FDA cleared 695 510(k)s from applicants in South Korea from January 2023 to September 2026, according to our count of FDA's public data. That is the third most of any country, after the US and China. Dental and radiology devices made up half of them.
Do I need a US Agent before submitting a 510(k)?
No. You can submit a 510(k) and receive clearance before naming a US Agent. You must register your site, list the device and name a US Agent before the device is imported into the US. Registration also requires paying the annual registration fee first.
How much does a 510(k) cost a Korean company in FY2027?
FDA's 510(k) fee for fiscal year 2027 is $28,653, or $7,163 for a qualifying small business. Annual establishment registration is $13,785. Testing, translation, a US Agent and any advisor are separate costs. They depend on your device type and how much testing your predicate comparison needs.
How does a Korean company qualify as an FDA small business?
Send FDA a MDUFA Small Business Request form and a certification from Korea's National Tax Service. It must show gross receipts in US dollars and won, with the exchange rate. Affiliates need certifications too. Combined receipts must be no more than $100 million. Apply at least 60 days before paying.
How long does FDA clearance take for Korean manufacturers?
Korean Traditional 510(k)s cleared from 2023 to September 2026 took a median of 175.5 days from receipt to clearance. That is about 9% longer than typical for the same device types. Most of the time is hold time while FDA waits for answers. Special 510(k)s took a median of 30 days.
Can I use test reports from a Korean lab?
Yes. FDA accepts reports from Korean labs if they meet its expectations: the FDA-recognized standard version, a complete report and an English translation. Two Korean labs are in FDA's ASCA program for basic safety and essential performance. Biocompatibility studies also need a statement on Good Laboratory Practice.
Does my Class I device need a 510(k)?
Usually not, but check. Most Class I device types are exempt, yet some are not. Patient examination gloves are Class I and still need a 510(k). Exemptions also have limits, such as a new intended use. Look up your product code in FDA's classification database before you plan.
Can I use a device sold in Korea as my predicate?
No. A predicate must be legally marketed in the US. That means a device cleared through a 510(k), marketed before May 28, 1976, or reclassified. You can search FDA's 510(k) database by product code to find predicates that Korean companies with similar devices have used.
What extra rules apply to X-ray and laser devices?
X-ray and laser devices are also radiation-emitting electronic products. X-ray systems and many lasers need a radiation safety product report before they enter commerce. The maker must also name a permanent US resident as its agent for legal notices before import. This is separate from the US Agent named in registration.
Does a 510(k) have to be in English?
Yes. FDA's acceptance checklist asks whether all content supporting the 510(k) is in English, including translations of test reports and literature. FDA uses the eSTAR template for 510(k)s, and registration and listing information must also be in English. Plan translation time into your schedule.
References
- openFDA. 510(k) API, decisions dated January 3, 2023 to September 27, 2026. Accessed October 12, 2026.
- openFDA. Registration and Listing API, establishments in South Korea. Accessed October 12, 2026.
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. Federal Register, July 30, 2026.
- eCFR. Title 21: Part 807, Establishment Registration and Device Listing (§§ 807.22, 807.40, 807.81, 807.92); § 880.9, Limitations of exemptions; § 812.28, Acceptance of clinical data to support medical device applications; § 1002.10, Product reports; § 1005.25, Service of process on manufacturers. Current as of October 2026.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Final guidance, October 2, 2023.
- FDA. Refuse to Accept Policy for 510(k)s. Final guidance, April 21, 2022.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Final guidance, October 3, 2022.
- FDA. Medical Device Single Audit Program (MDSAP). Content current as of December 19, 2025.
- FDA. Medical Devices; Quality System Regulation Amendments. Final rule, Federal Register, February 2, 2024, effective February 2, 2026.
- FDA. ASCA-Accredited Testing Laboratories database. Accessed October 12, 2026.
- FDA. Product Classification database. Accessed October 12, 2026.
- FDA. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Final guidance, September 8, 2023.