FDA product code MED: Sterilant, Medical Devices
MED is the FDA product code for sterilant, medical devices. It is a Class II device, regulated under 21 CFR 880.6885 and reviewed by the General Hospital panel. FDA has cleared 64 510(k) submissions under MED, 4 in the last five years, from 30 different applicants. The average 510(k) review took 270 days (median 175); 313 days on average over the last three years. FDA has posted 21 recalls for MED devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sterilant, Medical Devices |
| Device class | Class II |
| Regulation | 21 CFR 880.6885 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MED
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 175 |
| 2018 | 2 | 100 |
| 2019 | 4 | 85 |
| 2021 | 2 | 84 |
| 2022 | 1 | 29 |
| 2023 | 2 | 20 |
| 2026 | 1 | 313 |
Compare with all 510(k) review times · Search every MED clearance
Top MED applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 19 | 2026-04-08 |
| Advanced Sterilization Products | 5 | 2005-04-04 |
| Cottrell, Ltd. | 3 | 1999-09-13 |
| Metrex Research Corp. | 3 | 1994-12-06 |
| Steris Corporations | 2 | 2019-03-22 |
25 more applicants have MED clearances. See the full list in Caduvo.
Most recent MED clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251666 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | 2026-04-08 | 313 |
| K232914 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) | 2023-10-03 | 14 |
| K230582 | STERIS Corporation | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | 2023-03-28 | 26 |
| K222615 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | 2022-09-28 | 29 |
| K211607 | STERIS Corporation | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate | 2021-09-07 | 105 |
Recalls for MED devices
21 product recalls in 20 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code MED?
MED is the FDA product code for sterilant, medical devices. It is a Class II device, regulated under 21 CFR 880.6885 and reviewed by the General Hospital panel.
What device class is MED?
Class II, regulation 21 CFR 880.6885. Typical premarket route: 510(k).
How long does a 510(k) take for product code MED?
Across 64 cleared submissions the average was 270 days from receipt to decision (median 175).
Which companies have the most MED clearances?
STERIS Corporation (19); Advanced Sterilization Products (5); Cottrell, Ltd. (3); Metrex Research Corp. (3); Steris Corporations (2).
Have MED devices been recalled?
Yes: 21 product recalls across 20 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MED
- Run a recall and safety report across every MED manufacturer
- Watch product code MED for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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