FLEClass II
Sterilizer, Steam
21 CFR 880.6880 / General Hospital
FLE is the FDA product code for Sterilizer, Steam, a class II device type, regulated under 21 CFR 880.6880. As of , FDA records hold 185 510(k) clearances under this code, the most recent dated , and 18 recalls.
Classification record
- Product code
- FLE
- Device name
- Sterilizer, Steam
- Regulation
- 21 CFR 880.6880
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 185
- Ingested recalls
- 18
Clearances, product code FLE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 5 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 2 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 4 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 4 |
| 1990 | 7 |
| 1991 | 5 |
| 1992 | 4 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 8 |
| 1998 | 4 |
| 1999 | 4 |
| 2000 | 3 |
| 2001 | 5 |
| 2002 | 6 |
| 2003 | 5 |
| 2004 | 3 |
| 2006 | 3 |
| 2007 | 5 |
| 2008 | 1 |
| 2009 | 8 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 5 |
| 2013 | 5 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 8 |
| 2019 | 5 |
| 2020 | 2 |
| 2021 | 5 |
| 2022 | 10 |
| 2023 | 7 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 | 3 |
Applicants with the most clearances
Product code FLE| Applicant | Clearances |
|---|---|
| STERIS Corporation | 23 |
| Scican Ltd. | 13 |
| Tuttnauer Ltd. | 10 |
| Midmark Corp | 9 |
| Tuttnauer USA Co. Ltd. | 8 |
| Getinge/Castle, Inc. | 6 |
| PRIMUS Sterilizer Company LLC | 6 |
| Castle Co. | 5 |
| Getinge Sourcing, LLC | 5 |
| Sauter AG | 5 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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