BTLClass II
Ventilator, Emergency, Powered (Resuscitator)
21 CFR 868.5925 / Anesthesiology
BTL is the FDA product code for Ventilator, Emergency, Powered (Resuscitator), a class II device type, regulated under 21 CFR 868.5925. As of , FDA records hold 100 510(k) clearances under this code, the most recent dated , and 29 recalls.
Classification record
- Product code
- BTL
- Device name
- Ventilator, Emergency, Powered (Resuscitator)
- Regulation
- 21 CFR 868.5925
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 100
- Ingested recalls
- 29
Clearances, product code BTL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1980 | 2 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 2 |
| 1986 | 5 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 6 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 2 |
| 1995 | 5 |
| 1996 | 1 |
| 1998 | 6 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 5 |
| 2007 | 5 |
| 2008 | 4 |
| 2009 | 5 |
| 2010 | 3 |
| 2011 | 2 |
| 2013 | 1 |
| 2014 | 7 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code BTL| Applicant | Clearances |
|---|---|
| Allied Medical LLC | 9 |
| Life Support Products, Inc. | 8 |
| Pneupac, Ltd. | 8 |
| O-Two Systems Intl., Inc. | 7 |
| Vortran Medical Technology 1, Inc | 6 |
| ZOLL Medical Corporation | 5 |
| Life Corp. | 5 |
| O-Two Medical Technologies, Inc. | 5 |
| Abbott Medical | 3 |
| Thornhill Research Inc | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.