A 510(k) for a device labeled sterile should describe the sterilization method, how the cycle was validated, the sterility assurance level, and the packaging and its test methods. For established methods such as ethylene oxide and radiation, FDA wants descriptions rather than raw data, and any shelf life you claim needs aging and package testing behind it.
Key takeaways
- We searched the 510(k) summaries for devices FDA cleared in 2025: 365 stated a sterility assurance level of 10⁻⁶, and 242 stated a shelf life, most often 3 years.
- FDA's January 2024 guidance lists the sterility information a 510(k) should include. With it, FDA said it now considers vaporized hydrogen peroxide an Established Category A method.
- State a sterility assurance level of 10⁻⁶, unless the device only contacts intact skin, where FDA recommends 10⁻³.
- If you use a novel sterilization method, FDA asks for the validation data and intends to inspect the facility before clearance.
- Implants and devices that contact blood, lymph or cerebrospinal fluid should meet endotoxin limits: 20 EU per device, or 2.15 EU per device for cerebrospinal fluid contact.
What sterility information does a 510(k) need?
A short, specific set of facts. FDA's guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile", issued January 8, 2024, lists what to include for an established sterilization method [1]:
| Item | What to provide |
|---|---|
| Sterilization method | A description of the method, and of the chamber if it is not rigid and fixed, such as a flexible bag |
| Sterilization site | Where the device is sterilized, in this section or on Form 3514 |
| Radiation dose | For radiation sterilization |
| Sterilant residuals | For chemical sterilants such as ethylene oxide or hydrogen peroxide: the maximum residual levels on the device, and why they are acceptable for the device and its contact duration |
| Validation method | How the cycle was validated, for example the half-cycle method, but not the validation data |
| Standards | All consensus standards used, and any part of a standard you did not meet |
| Sterility assurance level | 10⁻⁶, or 10⁻³ for devices that only contact intact skin |
| Pyrogenicity | For devices that should meet pyrogen limits: the test method, the limit and why, and how often you test |
| Packaging | A description of the sterile barrier system, how it keeps the device sterile, and the package test methods, but not the test data |
For ethylene oxide residuals, FDA says it has accepted information based on the recognized version of ISO 10993-7 [1]. For Established Category B methods, also give the sterilizer's 510(k) number, make and model if it has one, and say whether its cleared cycles were changed [1].
The data stays in your quality system. For established methods, FDA asks you to describe the validation method, not to submit the data [1]. The data still has to exist. Sterilization in manufacturing is subject to FDA's quality system requirements [1].
The guidance covers industrial terminal sterilization that kills microorganisms. It does not cover aseptic processing or sterile filtration, devices made with animal or human tissue, liquid chemical sterilants, or reprocessed single-use devices [1].
Which sterilization methods does FDA consider established?
FDA sorts manufacturing sterilization methods into three groups, and the group decides how much you submit [1]:
| Category | Examples from FDA | What it means for your 510(k) |
|---|---|---|
| Established Category A | Dry heat, ethylene oxide in a fixed rigid chamber, moist heat or steam, radiation such as gamma and electron beam, vaporized hydrogen peroxide | Long history of safe use and FDA-recognized standards. Submit the descriptions in the table above |
| Established Category B | Ozone, flexible bag systems such as ethylene oxide in a flexible bag | No dedicated recognized standard, but published information exists and FDA has evaluated specific cycles. Add the sterilizer and cycle details |
| Novel | Vaporized peracetic acid, high intensity or pulsed light, microwave radiation, sound waves, ultraviolet light | Little published information and no recognized standard. Submit a full process description, the validation protocol and the validation data |
Novel methods bring an inspection. FDA says novel sterilization technologies carry a substantial risk of inadequate sterility assurance. It intends to inspect the manufacturing facility before clearing a 510(k) for a device sterilized by a novel process [1].
Vaporized hydrogen peroxide is now Category A. When FDA issued the January 2024 guidance, it said it now considers vaporized hydrogen peroxide an Established Category A process [9]. A 510(k) using it follows the same route as one using ethylene oxide or radiation.
Changed cycles can become novel. If you alter the parameters of an FDA-cleared sterilizer, or FDA has not evaluated the process validation before, FDA treats the method as novel [1]. FDA also notes the categories can change over time [1].
What sterility assurance level should you state?
10⁻⁶ for most devices. FDA says to state a sterility assurance level (SAL) of 10⁻⁶ for devices labeled sterile, unless the device is intended only to contact intact skin. For those, FDA recommends 10⁻³ [1].
For any other SAL, FDA recommends direct consultation and a Pre-Submission [1, 8]. Our Q-Submission hub explains how to request one.
When do you need endotoxin or pyrogen testing?
When the device is an implant, contacts blood, lymph or cerebrospinal fluid, or is labeled non-pyrogenic. FDA lists these categories [1]:
- implants
- devices in direct or indirect contact with the cardiovascular system, the lymphatic system or cerebrospinal fluid, including devices present for similar systemic exposure
- devices labeled non-pyrogenic
For these, FDA recommends bacterial endotoxin limits of 20 EU per device for general devices, and 2.15 EU per device for devices that contact cerebrospinal fluid [1]. In your 510(k), describe the test method, such as the bacterial endotoxins test (also called the LAL test), the limit and why you chose it, and whether you test every batch or follow a sampling plan [1].
Two wording points. FDA recommends "non-pyrogenic" or "meets pyrogen limit specifications" instead of "pyrogen free" [1]. And endotoxins are not the only source of pyrogens. Chemicals that leach from device materials can cause fever too. FDA says these material-mediated pyrogens are usually addressed in the biocompatibility assessment [1]. Our biocompatibility guide covers that testing.
What packaging information should a 510(k) include?
A description and the test methods, not the test data. FDA asks for a description of the sterile barrier system, how it will keep the device sterile, and the package test methods [1].
FDA recommends that package testing include [1]:
- simulated distribution, with package integrity testing afterwards
- simulated aging, real-time aging or both, with seal strength testing afterwards
- methods from the currently FDA-recognized version of the ISO 11607 series, "Packaging for terminally sterilized medical devices"
Together these support two claims: that the package survives shipping, and that it stays sealed for the full shelf life [1]. Our packaging requirements guide covers ISO 11607 in more depth, and our guide to choosing a sterilization method compares the main methods.
How do you support a shelf life claim?
With aging data on both the device and its package. FDA defines shelf life as the period during which a product remains suitable for its intended use. The expiration date marks its end [2].
Not every device needs one. FDA's shelf life guidance says the device must be analyzed for degradation that could lead to functional failure, and the risk that failure would pose. For some devices, such as tongue depressors, FDA says assigning a shelf life is not reasonable [2].
Accelerated aging needs real-time follow-up. FDA's guidance accepts accelerated aging to set a tentative shelf life, but says the results need to be supported by real-time testing of shelf life samples [2]. Its 2024 sterility guidance recommends simulated and/or real-time aging with seal strength testing to validate shelf life claims [1].
Two things age. The package must stay sealed, and the device must still perform. Plan aging tests for both, so your expiration date covers the weaker of the two.
Label the date correctly. If your label carries an expiration date, it must be in year-month-day format with four digits for the year, such as 2028-01-02 [3]. Our labeling requirements guide covers the rest of Part 801. Complizen's Label Review checks storage, handling and expiry statements against 21 CFR Part 801 before you print.
FDA's shelf life guidance dates from April 1991 and quotes quality system rules that have since been replaced [2]. Use it for its principles, and check your test plan against the current recognized standards [7].
What do 2025 510(k) summaries show?
We searched the public 510(k) summaries for all 3,070 devices FDA cleared in 2025 that have one [4, 5]. Counts show summaries that cite each item at least once:
| Item cited in the 510(k) summary | Summaries |
|---|---|
| Sterility assurance level of 10⁻⁶ | 365 |
| Sterility assurance level of 10⁻³ | 7 |
| ISO 11135, ethylene oxide sterilization | 249 |
| ISO 11137, radiation sterilization | 131 |
| ISO 17665, moist heat (steam) sterilization | 128 |
| ISO 22441, vaporized hydrogen peroxide | 9 |
| ISO 10993-7, ethylene oxide residuals | 135 |
| ISO 11607, packaging | 186 |
| ASTM F1980, accelerated aging | 179 |
| ASTM D4169, distribution testing | 153 |
| Bacterial endotoxin or LAL testing | 126 |
What stands out. Ethylene oxide is the most cited sterilization standard, with almost twice the summaries of radiation. Accelerated aging (ASTM F1980) and packaging (ISO 11607) are cited about equally often, which fits FDA's advice to validate the package and the shelf life together [1]. Note that ISO 17665 also appears in instructions for steam-sterilizing reusable devices, not only in factory sterilization.
Shelf lives claimed in 2025. 242 summaries stated a shelf life. We took the first value each stated:
| Stated shelf life | Summaries |
|---|---|
| Under 1 year | 20 |
| 1 year to under 2 years | 38 |
| 2 years to under 3 years | 50 |
| 3 years to under 5 years | 91 |
| 5 years or more | 43 |
The most common single value was 3 years (87 summaries), then 2 years (48) and 5 years (42). The median was 3 years.
How we counted. We extracted the text of each public 510(k) summary and searched for each standard's number, the SAL values and stated shelf life periods. A summary that cites a standard may use it for the device, for a reference device or for user reprocessing, and summaries vary in detail. Treat the counts as a guide to common practice, not a requirement.
What if your device is sold non-sterile?
Then the 510(k) sterility guidance does not cover your user's sterilization step. Reusable devices that hospitals reprocess, and single-use devices sold non-sterile for the user to sterilize, fall under FDA's separate reprocessing guidance [1, 6].
That guidance covers the cleaning, disinfection and sterilization instructions you give users, and how you validate them [6]. If your device is reusable, plan that validation alongside your other testing.
How do you put this into your 510(k)?
Treat sterility, packaging and shelf life as one connected part of your 510(k), alongside your other performance testing. The same sterile barrier system that passed your sterilization validation should be the one you age, ship and seal-test.
- Confirm your method's category. If it is novel, or you changed a cleared cycle, expect to submit data and plan for an inspection [1].
- List every standard and the version. FDA asks you to identify all standards used and any part you did not meet [1]. Test reports prepared for CE marking often use the same ISO standards. Check that the version matches FDA's recognized version, or explain the difference [7].
- Set your endotoxin plan early if your device is an implant or contacts blood, lymph or cerebrospinal fluid [1].
- Choose a shelf life you can support, and start real-time aging when you start accelerated aging [2].
Complizen's 510(k) Submission service drafts the sterility and shelf life section from your lab's validation reports, and tells you which tests are still missing before any are ordered. Reports prepared for CE marking are worth sending, since some may already count.
Frequently asked questions
What sterility shelf life information does a 510(k) need?
For a device labeled sterile, a 510(k) should describe the sterilization method, site, validation method and sterility assurance level, plus residuals, pyrogenicity where relevant, and the packaging and its test methods. For a shelf life claim, it should show aging and package integrity testing that supports the expiration date.
Does FDA require sterilization validation data in a 510(k)?
Not for established methods. FDA asks for a description of how you validated the cycle, such as the half-cycle method, but not the data itself. For novel sterilization methods, FDA asks for the full validation protocol and data, and intends to inspect the facility before clearance.
What sterility assurance level does FDA expect?
FDA recommends stating a sterility assurance level of 10⁻⁶ for devices labeled sterile. For devices intended only to contact intact skin, FDA recommends 10⁻³. For any other level, FDA recommends consulting it directly, for example through a Pre-Submission, before you submit.
Is vaporized hydrogen peroxide an established sterilization method?
Yes. FDA's January 2024 sterility guidance lists vaporized hydrogen peroxide as an Established Category A method, alongside dry heat, ethylene oxide in a fixed rigid chamber, steam and radiation. FDA recommends contacting the review division about parameters for parametric release with this method.
What counts as a novel sterilization method?
FDA lists examples such as vaporized peracetic acid, pulsed light, microwave radiation, sound waves and ultraviolet light. A changed cycle on a cleared sterilizer, or a process FDA has not evaluated before, can also count as novel. Novel methods need full validation data in the 510(k).
What are FDA's endotoxin limits for medical devices?
FDA recommends 20 endotoxin units per device for general devices, such as blood-contacting and implanted devices, and 2.15 endotoxin units per device for devices that contact cerebrospinal fluid. Limits can vary for specific device types, so check with the review branch for your device.
Do I need to submit package test data in a 510(k)?
No. FDA asks for a description of the sterile barrier system, how it keeps the device sterile, and the package test methods, but not the test data. FDA recommends simulated distribution, integrity, aging and seal strength testing using the recognized ISO 11607 series.
Can I use accelerated aging to set a shelf life?
Yes, to set a tentative shelf life. FDA's shelf life guidance says accelerated aging results need to be supported by real-time testing of shelf life samples. FDA's 2024 sterility guidance recommends simulated and/or real-time aging, with seal strength testing, to validate shelf life claims.
Does every device need a shelf life?
No. FDA's shelf life guidance says you should analyze whether the device can degrade in a way that leads to failure, and the risk that would pose. For some devices, such as tongue depressors, FDA says assigning a shelf life is not reasonable.
What is the most common shelf life in a 510(k)?
In our review of 2025 510(k) summaries, 242 stated a shelf life. The most common value was 3 years, stated in 87 summaries, followed by 2 years in 48 and 5 years in 42. The median was 3 years. Twenty summaries stated less than one year.
How should the expiration date appear on the label?
Under 21 CFR 801.18, a printed expiration date must show the year in four digits, then the month and day in two digits each, separated by hyphens. For example, January 2, 2028 appears as 2028-01-02. A few exceptions apply, such as some combination products.
Does the sterility guidance apply to reusable devices?
No. Cleaning, disinfection and sterilization of reusable devices in healthcare settings, and single-use devices sold non-sterile for the user to sterilize, fall under FDA's separate guidance on reprocessing medical devices in health care settings. It covers how to validate your user instructions and how to label them.
References
- FDA. Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. Final guidance, January 8, 2024.
- FDA. Shelf Life of Medical Devices. Guidance, April 1991.
- eCFR. 21 CFR 801.18, Format of dates provided on a medical device label. Up to date as of October 7, 2026.
- openFDA. 510(k) API, decisions dated January 1 to December 31, 2025. Accessed October 9, 2026.
- FDA. 510(k) Premarket Notification database, 510(k) summaries for 2025 clearances. Accessed October 9, 2026.
- FDA. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Final guidance, March 2015.
- FDA. Recognized Consensus Standards database. Accessed October 9, 2026.
- FDA. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Final guidance, May 29, 2025.
- FDA. FDA Roundup: January 9, 2024. Press announcement, January 9, 2024.