CBFClass II
Chamber, Hyperbaric
21 CFR 868.5470 / Anesthesiology
CBF is the FDA product code for Chamber, Hyperbaric, a class II device type, regulated under 21 CFR 868.5470. As of , FDA records hold 69 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- CBF
- Device name
- Chamber, Hyperbaric
- Regulation
- 21 CFR 868.5470
- 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
- Yes
- Ingested clearances
- 69
- Ingested recalls
- 3
Clearances, product code CBF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 1995 | 5 |
| 1996 | 5 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 4 |
| 2001 | 4 |
| 2002 | 6 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code CBF| Applicant | Clearances |
|---|---|
| Reimers Systems, Inc. | 5 |
| Sechrist Industries Inc | 5 |
| Environmental Tectonics Corp. | 3 |
| Gulf Coast Hyperbarics, Inc. | 3 |
| Pan-America Hyperbarics, Inc. | 3 |
| Perry Baromedical Corporation | 3 |
| Perry Baromedical Services | 3 |
| Fink Engineering Pty Ltd | 2 |
| Hyperbaric Technologies, Inc. | 2 |
| Hypertec, Inc. | 2 |
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.