KCYClass I
Tourniquet, Pneumatic
21 CFR 878.5910 / General, Plastic Surgery
KCY is the FDA product code for Tourniquet, Pneumatic, a class I device type, regulated under 21 CFR 878.5910. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 47 recalls.
Classification record
- Product code
- KCY
- Device name
- Tourniquet, Pneumatic
- Regulation
- 21 CFR 878.5910
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 34
- Ingested recalls
- 47
Clearances, product code KCY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1981 | 1 |
| 1984 | 3 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 6 |
| 1996 | 1 |
| 2001 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code KCY| Applicant | Clearances |
|---|---|
| Aspen Laboratories, Inc. | 5 |
| Instrumed, Inc. | 5 |
| Zimmer GmbH | 2 |
| Arthrex GmbH | 1 |
| Avec Scientific Design Corp. | 1 |
| Crantec Co. | 1 |
| Depuy, Inc. | 1 |
| DeRoyal Industries, Inc. | 1 |
| DJ Medical, Inc. | 1 |
| Dominion Medical Devices, LLC | 1 |
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.