FDA product code FLE: Sterilizer, Steam
FLE is the FDA product code for sterilizer, steam. It is a Class II device, regulated under 21 CFR 880.6880 and reviewed by the General Hospital panel. FDA has cleared 185 510(k) submissions under FLE, 26 in the last five years, from 84 different applicants. The average 510(k) review took 184 days (median 135); 149 days on average over the last three years. FDA has posted 18 recalls for FLE devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sterilizer, Steam |
| Device class | Class II |
| Regulation | 21 CFR 880.6880 |
| 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 FLE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 205 |
| 2018 | 8 | 180 |
| 2019 | 5 | 254 |
| 2020 | 2 | 138 |
| 2021 | 5 | 168 |
| 2022 | 10 | 145 |
| 2023 | 7 | 154 |
| 2024 | 2 | 148 |
| 2025 | 4 | 199 |
| 2026 | 3 | 99 |
Compare with all 510(k) review times · Search every FLE clearance
Top FLE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 22 | 2026-06-24 |
| Tuttnauer U.S.A Co, Ltd. | 8 | 2023-11-27 |
| Scican , Ltd. | 7 | 2022-03-31 |
| Midmark Corp. | 7 | 2009-07-07 |
| Tuttnauer Co. , Ltd. | 6 | 2011-12-08 |
79 more applicants have FLE clearances. See the full list in Caduvo.
Most recent FLE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261055 | STERIS Corporation | AMSCO 700 Steam Sterilizer | 2026-06-24 | 85 |
| K260254 | Enbio Group AG | Enbio PRO | 2026-02-26 | 30 |
| K252307 | Maquet GmbH (A Getinge Group Company) | Getinge GSS67N Series Steam Sterilizer | 2026-01-22 | 182 |
| K250168 | Lucas Lifecare | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | 2025-12-30 | 343 |
| K250164 | Guangzhou Ajax Medical Equipment Co., Ltd. | Cassette Autoclave (ACA5) | 2025-08-14 | 205 |
Recalls for FLE devices
18 product recalls in 17 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2026-07-08.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 3 |
| 2021 | 1 |
| 2023 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FLE?
FLE is the FDA product code for sterilizer, steam. It is a Class II device, regulated under 21 CFR 880.6880 and reviewed by the General Hospital panel.
What device class is FLE?
Class II, regulation 21 CFR 880.6880. Typical premarket route: 510(k).
How long does a 510(k) take for product code FLE?
Across 185 cleared submissions the average was 184 days from receipt to decision (median 135).
Which companies have the most FLE clearances?
STERIS Corporation (22); Tuttnauer U.S.A Co, Ltd. (8); Scican , Ltd. (7); Midmark Corp. (7); Tuttnauer Co. , Ltd. (6).
Have FLE devices been recalled?
Yes: 18 product recalls across 17 recall events; the most recent began 2026-07-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FLE
- Run a recall and safety report across every FLE manufacturer
- Watch product code FLE 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times