KDDClass I
Kit, Surgical Instrument, Disposable
21 CFR 878.4800 / General, Plastic Surgery
KDD is the FDA product code for Kit, Surgical Instrument, Disposable, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 62 510(k) clearances under this code, the most recent dated , and 250 recalls.
Classification record
- Product code
- KDD
- Device name
- Kit, Surgical Instrument, Disposable
- Regulation
- 21 CFR 878.4800
- 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
- 62
- Ingested recalls
- 251
Clearances, product code KDD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 3 |
| 1978 | 2 |
| 1980 | 6 |
| 1981 | 4 |
| 1982 | 6 |
| 1983 | 4 |
| 1984 | 7 |
| 1985 | 3 |
| 1987 | 4 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 5 |
| 1992 | 4 |
| 1993 | 6 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 2001 | 1 |
| 2008 | 1 |
Applicants with the most clearances
Product code KDD| Applicant | Clearances |
|---|---|
| American Medical Disposable, Inc. | 3 |
| Pro-Pak | 3 |
| Ulti-Med Intl., Inc. | 3 |
| American Hospital Supply | 2 |
| E.M. Adams Co., Inc. | 2 |
| Megadyne Medical Products, Inc | 2 |
| Megaplast, Inc. | 2 |
| Pollak (Intl.).ltd | 2 |
| Ackrad Laboratories | 1 |
| Akla, Inc. | 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.
