KYTClass I
Light, Examination, Medical, Battery Powered
21 CFR 880.6350 / General Hospital
KYT is the FDA product code for Light, Examination, Medical, Battery Powered, a class I device type, regulated under 21 CFR 880.6350. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- KYT
- Device name
- Light, Examination, Medical, Battery Powered
- Regulation
- 21 CFR 880.6350
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 1
Clearances, product code KYT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1984 | 2 |
| 1992 | 1 |
Applicants with the most clearances
Product code KYT| Applicant | Clearances |
|---|---|
| Suncoast Medical Manufacturers, Inc. | 2 |
| Abco Dealers, Inc. | 1 |
| Concept, Inc. | 1 |
| Olympic Medical Corp. | 1 |
| Taylor Instrument Analytics Co. | 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.
