KYT
6 FDA 510(k) clearances · Product code
36 daysmedian time to decision
83 days90th percentile
6clearances measured
FDA profile
- Official device name
- Light, Examination, Medical, Battery Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6350
- Medical specialty
- General Hospital
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OLYMPIC TRANS-LITE (K920782) | Olympic Medical Corp. | 1992-03-27 |
| SUN-LITE WHITE SPOT (K841588) | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| C-LITE (K841589) | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| PENLIGHT/SWAB HOLDER (K791001) | Concept, Inc. | 1979-06-22 |
| PENLIGHTS (K781228) | Abco Dealers, Inc. | 1978-09-07 |
| TYCOS DIAGNOSTIC PENLIGHT (K760972) | Taylor Instrument Analytics Co. | 1977-01-26 |
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Every clearance here is in the API, with alerts when new ones post.