CACClass II
Apparatus, Autotransfusion
21 CFR 868.5830 / Anesthesiology
CAC is the FDA product code for Apparatus, Autotransfusion, a class II device type, regulated under 21 CFR 868.5830. As of , FDA records hold 195 510(k) clearances under this code, the most recent dated , and 89 recalls.
Classification record
- Product code
- CAC
- Device name
- Apparatus, Autotransfusion
- Regulation
- 21 CFR 868.5830
- 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
- 195
- Ingested recalls
- 89
Clearances, product code CAC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 5 |
| 1979 | 1 |
| 1981 | 4 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 6 |
| 1986 | 3 |
| 1987 | 11 |
| 1988 | 14 |
| 1989 | 11 |
| 1990 | 20 |
| 1991 | 12 |
| 1992 | 5 |
| 1993 | 10 |
| 1994 | 6 |
| 1995 | 6 |
| 1996 | 8 |
| 1997 | 8 |
| 1998 | 8 |
| 1999 | 6 |
| 2001 | 1 |
| 2002 | 6 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 4 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 3 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 3 |
Applicants with the most clearances
Product code CAC| Applicant | Clearances |
|---|---|
| Haemonetics Corporation | 18 |
| Boehringer Laboratories, LLC | 12 |
| Deknatel, Inc. | 11 |
| Shiley, Inc. | 11 |
| Atrium Medical Corporation | 10 |
| LivaNova USA, Inc. | 7 |
| Electromedics, Inc. | 7 |
| Solco Basle, Inc. | 7 |
| Sorensen Research | 7 |
| Corcym Inc. | 6 |
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.