FDA review time by country varies widely: Traditional 510(k)s cleared from 2023 to September 2026 took a median of 151 days, from 126 days for applicants in Ireland and Spain to 234 for Taiwan. Most of that is time on hold, not FDA's clock, since FDA met its 90-day goal for at least 97% of 510(k)s each year.
Key takeaways
- We measured all 9,990 Traditional 510(k)s cleared from January 1, 2023 to September 27, 2026. The median was 151 days from receipt to clearance, and about one in four cleared within 90 days.
- FDA met its goal of a decision within 90 FDA days for 99.3%, 98.8% and 97.9% of 510(k)s in fiscal years 2023, 2024 and 2025. The rest of the calendar time is mostly holds while applicants answer FDA's questions.
- Among large applicant countries, Japan (139 days), China (140) and the US (142) were fastest, while Germany (196), India (207) and Taiwan (234) were slowest.
- Device type explains part of the gap. Compared with the median for the same device type, South Korean 510(k)s took 9% longer, and Indian and Taiwanese 510(k)s 21% longer.
- Special 510(k)s cleared in a median of 29 days, and Traditional 510(k)s with a third-party review in a median of 28 days.
How long does a 510(k) take from submission to clearance?
About five months, at the median. We analyzed every 510(k) that FDA found substantially equivalent from January 1, 2023 to September 27, 2026, the latest decision date in openFDA when we pulled the data on October 9, 2026 [1]. For Traditional 510(k)s, the days from FDA receipt to clearance were:
| Measure | Days |
|---|---|
| Fastest quarter cleared within | 90 |
| Median | 151 |
| Average | 178 |
| Slowest quarter took more than | 245 |
The type of 510(k) matters more than anything else [1]:
| 510(k) type | Cleared | Median days |
|---|---|---|
| Traditional | 9,990 | 151 |
| Special | 1,863 | 29 |
| Abbreviated | 150 | 142 |
| Dual 510(k) and CLIA waiver | 55 | 214 |
Our 510(k) hub explains how the three main types differ.
Why does it take longer than FDA's 90-day goal?
Because the 90 days are FDA days, not calendar days. Under the MDUFA V agreement, FDA days are the days a submission is under review at FDA, starting from receipt of a submission that FDA accepts [2]. Days the 510(k) spends on hold, waiting for the applicant, do not count.
FDA's own performance data shows the difference. FDA reached a decision within 90 FDA days for 99.3% of 510(k)s in fiscal year 2023, 98.8% in 2024 and 97.9% in 2025, against a goal of 95% [3]. FDA marks 2025 as preliminary [3]. Yet in calendar days, the median Traditional 510(k) took 151 days [1].
Two kinds of hold make up most of the gap:
- Refuse to Accept holds. If FDA's acceptance or technical screening finds the 510(k) incomplete, FDA days start only when FDA receives the amendment that lets it accept the file [2]. Our RTA guide covers how to avoid it, and Complizen's free Gap Assessment checks your device documents against what a 510(k) needs before you file.
- Additional Information holds. When FDA needs more information, it sends an Additional Information (AI) request and places the 510(k) on hold from the date of the request [4]. FDA's current policy allows up to 180 calendar days to send a complete response. After that, FDA considers the 510(k) withdrawn [4].
MDUFA V also sets a shared goal for FDA and industry together: an average total time to decision of 112 calendar days for 510(k)s received in fiscal years 2025 to 2027 [2]. That figure is calculated differently from ours. It counts from an accepted submission and excludes some submissions with long holds [2]. So it is not directly comparable with our medians.
How do review times compare by country?
Widely. This table shows Traditional 510(k)s cleared from January 2023 to September 2026, by the applicant's country in FDA's database, for every country with at least 40 such clearances, plus Malaysia and Turkey [1]:
| Applicant country | All 510(k)s cleared | Traditional 510(k)s | Median days | Cleared within 90 days | Compared with same device type |
|---|---|---|---|---|---|
| Ireland | 103 | 76 | 126 | 32% | 6% faster |
| Spain | 92 | 79 | 126 | 33% | 11% faster |
| Japan | 249 | 211 | 139 | 27% | 8% faster |
| Switzerland | 232 | 198 | 139 | 28% | Same |
| China | 1,997 | 1,849 | 140 | 29% | Same |
| United States | 5,840 | 4,615 | 142 | 27% | 1% faster |
| Brazil | 73 | 69 | 148 | 28% | 6% faster |
| Singapore | 61 | 45 | 154 | 18% | 4% faster |
| France | 263 | 208 | 154.5 | 22% | Same |
| Malaysia | 58 | 48 | 156.5 | 21% | 34% slower |
| Netherlands | 121 | 93 | 158 | 23% | 2% slower |
| Israel | 332 | 263 | 159 | 24% | 2% slower |
| Canada | 198 | 163 | 167 | 18% | Same |
| Italy | 191 | 146 | 167.5 | 25% | 12% slower |
| United Kingdom | 215 | 184 | 170.5 | 21% | Same |
| South Korea | 695 | 582 | 175.5 | 24% | 9% slower |
| Australia | 98 | 80 | 185 | 12% | 13% slower |
| Turkey | 28 | 28 | 186 | 18% | 22% slower |
| Sweden | 85 | 76 | 190 | 11% | 2% slower |
| Germany | 420 | 363 | 196 | 21% | 4% slower |
| Denmark | 72 | 63 | 197 | 11% | 5% slower |
| India | 84 | 78 | 207 | 14% | 21% slower |
| Taiwan | 213 | 186 | 234 | 16% | 21% slower |
Small samples move a lot from year to year. Turkey had 28 Traditional clearances in the period, and Malaysia 48, so treat their figures as indications only.
Which device types take longest?
Device type changes the clock as much as country does. Among device types with at least 60 Traditional clearances in the period, medians ranged from 84 days to 260 days [1]:
| Device type (FDA product code) | Traditional 510(k)s | Median days |
|---|---|---|
| Over-the-counter light-based hair removal (OHT) | 77 | 84 |
| Thoracolumbosacral pedicle screw systems (NKB) | 90 | 88 |
| Powered laser surgical instruments (GEX) | 232 | 94 |
| Bone fixation plates (HRS) | 159 | 98 |
| Polymer patient examination gloves (LZA) | 95 | 102 |
| Electrosurgical cutting and coagulation devices (GEI) | 187 | 140 |
| Automated radiological image processing software (QIH) | 239 | 154 |
| Non-invasive blood pressure systems (DXN) | 93 | 175 |
| Root-form dental implants (DZE) | 114 | 218 |
| Drug-containing wound dressings (FRO) | 63 | 260 |
This is why a country's raw median can mislead. Root-form dental implants, a large Korean export, take a median of 218 days for every applicant. To find your own device's figure, look up recent clearances for your product code in FDA's 510(k) database [8].
Is it the country or the device type?
Partly the device type. Some device types simply take longer, so a country that exports many of them will look slow. To separate the two, we compared each clearance with the median time for its FDA product code, across all countries, then took each country's median. This covered the 85% of Traditional clearances whose product code had at least five clearances in the period [1].
The adjustment changes the picture in both directions:
- South Korea looks 16% slower than the overall median (175.5 against 151 days), but only 9% slower than typical for the same device types.
- Germany looks 30% slower (196 days), but only 4% slower once device type is taken into account.
- Malaysia looks close to average (156.5 days), but is 34% slower than typical for the same device types.
- Taiwan and India stay slower after the adjustment, by 21% each.
What remains after the adjustment is mostly hold time: how complete the submission was and how quickly the applicant answered FDA. Our data cannot show which, because openFDA does not record holds [1].
What makes some 510(k)s much faster?
Two routes stand out in the data [1]:
- Special 510(k). For changes to your own cleared device, FDA says it generally reviews Special 510(k)s within 30 days of receipt [5]. The median in our data was 29 days. If FDA decides a change does not fit the Special program, it converts the submission to a Traditional 510(k) [5].
- Third-party review. Traditional 510(k)s with a third-party review flag cleared in a median of 28 days, against 154 days for the rest. FDA aims to decide within 30 days of receiving the review organization's recommendation [6]. FDA says about half of the 510(k)s it receives are eligible, and there is no FDA user fee for them; you pay the review organization instead [6]. Only 212 of 9,990 Traditional clearances used it. Our third-party review guide explains eligibility.
The review organization does its own review before FDA receives the file, so the full time from start to clearance is likely longer than these figures show.
How have review times changed since 2023?
They improved, then rose a little in 2026. The median Traditional 510(k) cleared in 2023 took 161 days, then 150.5 days in 2024, 142 in 2025, and 153 in 2026 so far [1].
| Applicant country | 2023 | 2024 | 2025 | 2026 to Sept. 27 |
|---|---|---|---|---|
| All applicants | 161 | 150.5 | 142 | 153 |
| United States | 150 | 140 | 133.5 | 147 |
| China | 152 | 139 | 132 | 146 |
| South Korea | 168 | 182.5 | 169.5 | 182.5 |
| Japan | 193.5 | 142 | 121 | 144.5 |
| Germany | 194 | 230.5 | 203 | 168 |
| Taiwan | 264 | 166.5 | 197 | 242.5 |
Figures for 2026 cover only clearances so far, and the slowest 2026 submissions are still in review. Countries with fewer clearances, such as India, Malaysia and Turkey, swing too much by year to show here.
How can you shorten your own 510(k) timeline?
Reduce the time your 510(k) spends on hold. FDA's own clock is already close to its goal [3]. The days you control are the ones before FDA accepts the file and the ones spent answering its questions.
- Submit a complete eSTAR. If FDA cannot accept your file, FDA days start only once your fix arrives [2]. Our eSTAR guide covers the template.
- Ask FDA before you test, if the pathway or testing is unclear. A Pre-Submission gets written feedback, which FDA aims to send within 70 days [7]. Our Q-Submission hub explains when it pays off.
- Answer AI requests completely, and fast. You have up to 180 days, but every day counts toward your total, and FDA expects a complete response to every deficiency in the request [4]. Complizen's FDA Correspondence tool reads the AI request, builds a response plan and drafts point-by-point replies with citations.
- Check whether you qualify for a faster route. Use a Special 510(k) for changes to your own device, and check third-party review eligibility [5, 6].
If you are outside the US, decide before you submit who will answer FDA's questions, and how fast, across time zones and languages. For your own market, see our international path and our guide to what an MFDS licence does and does not change.
How we did it. We took every 510(k) in openFDA with a decision date from January 1, 2023 to September 27, 2026 and a substantially equivalent decision. Review days are calendar days from the date FDA received the 510(k) to the decision date. Country is the applicant's country in FDA's database, which can differ from where the device is made. We used medians, because a few very long reviews pull averages up. The data covers cleared 510(k)s only. Submissions that were withdrawn or found not substantially equivalent are not included [1, 8].
Frequently asked questions
What is the average FDA review time by country?
FDA review time by country ranged from a median of 126 days for applicants in Ireland and Spain to 234 days for Taiwan, for Traditional 510(k)s cleared from January 2023 to September 2026. The median for all applicants was 151 days from receipt to clearance, and the average was 178 days.
How long does a 510(k) take in 2026?
Traditional 510(k)s cleared in 2026, up to September 27, took a median of 153 days from receipt to clearance. That is slightly longer than 2025's 142 days. Some slower 2026 submissions are still in review, so the final 2026 figure may change.
Is FDA's 510(k) review really 90 days?
FDA's goal is a decision within 90 FDA days, which excludes time on hold waiting for the applicant. FDA met it for 97.9% to 99.3% of 510(k)s in fiscal years 2023 to 2025. In calendar days, the median Traditional 510(k) took 151 days from receipt to clearance.
Why do 510(k)s from some countries take longer?
Partly device type, and mostly hold time. Some device types take longer for every applicant. After adjusting for device type, South Korean 510(k)s took 9% longer than typical and Taiwanese and Indian 510(k)s 21% longer. The remaining difference comes from holds, which openFDA does not record.
How long do South Korean 510(k)s take?
Korean Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 175.5 days from receipt to clearance, against 151 days for all applicants. Compared with the same device types, Korean 510(k)s took about 9% longer. South Korea had 695 clearances in the period.
How long do Japanese 510(k)s take?
Japanese Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 139 days, among the fastest of any large applicant country. Compared with the same device types, they took about 8% less time than typical. Japan had 249 clearances in the period.
How long do Chinese 510(k)s take?
Chinese Traditional 510(k)s cleared from January 2023 to September 2026 took a median of 140 days, close to the US median of 142 days. China was the second-largest source of 510(k) clearances, with 1,997, and its times matched the typical time for the same device types.
How long does a Special 510(k) take?
Special 510(k)s cleared from January 2023 to September 2026 took a median of 29 days from receipt to clearance. FDA says it generally reviews Special 510(k)s within 30 days. They are for changes to your own cleared device, and FDA converts unsuitable ones to Traditional 510(k)s.
Does third-party review make a 510(k) faster?
In our data, yes. Traditional 510(k)s with third-party review cleared in a median of 28 days from FDA's receipt, against 154 days for the rest. FDA aims to decide within 30 days of the review organization's recommendation. The organization's own review time comes before FDA receives the file.
How long do I have to answer an FDA AI request?
FDA's current policy allows up to 180 calendar days from the date of the Additional Information request to send a complete response. If FDA does not receive a complete response in that time, it considers the 510(k) withdrawn. The 510(k) is on hold while you prepare the response.
Does the applicant's country change how FDA reviews a 510(k)?
FDA applies the same standard and the same review goals to every 510(k). The differences in our data come from device mix and from hold time, such as how complete the submission was and how quickly the applicant answered FDA's questions.
Where does this review time data come from?
From FDA's own 510(k) database, through openFDA. We measured calendar days from the date FDA received each 510(k) to its clearance date, for clearances from January 1, 2023 to September 27, 2026. Country is the applicant's country as recorded by FDA.
References
- openFDA. 510(k) API, decisions dated January 1, 2023 to September 27, 2026. Accessed October 9, 2026.
- FDA. MDUFA V Commitment Letter, Sections I.B and VIII. 2022.
- FDA. FDA-TRACK: MDUFA Quarterly Performance Dashboards, 510(k), with the 510(k) dataset. Content current as of June 30, 2026.
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Final guidance, October 3, 2022.
- FDA. The Special 510(k) Program. Final guidance, September 13, 2019.
- FDA. 510(k) Third Party Review Program. Content current as of November 20, 2024.
- FDA. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Final guidance, May 29, 2025.
- FDA. 510(k) Premarket Notification database. Accessed October 12, 2026.