FOK
5 FDA 510(k) clearances · Product code
30 daysmedian time to decision
102 days90th percentile
5clearances measured
FDA profile
- Official device name
- Pad, Neonatal Eye
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5270
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2003: 1 · 2016: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER (K962290) | Debusk Technology Corp. | 1996-07-03 |
| LIFE TRACE(R) BILIRUBIN MASK (K926118) | Graphic Controls Corp. | 1993-03-15 |
| INFANT PHOTOTHERAPY MASK (K851918) | Alba Health Care | 1985-06-07 |
| PHOTO-THERAPY EYE PROTECTOR (K840894) | A & A Medical Supplies Co. | 1984-03-23 |
| INFANT PHOTOTHERAPY MASK (K813214) | Montrose Phototherapy Supply | 1981-12-09 |
Track FOK automatically
Every clearance here is in the API, with alerts when new ones post.