FRL
19 FDA 510(k) clearances · Product code
39 daysmedian time to decision
244 days90th percentile
19clearances measured
FDA profile
- Official device name
- Fiber, Medical, Absorbent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5300
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2017: 10 · 2018: 21 · 2019: 13 · 2020: 26 · 2021: 13 · 2026: 34
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 |
|---|---|---|
| STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (K121898) | Quick-Med Technologies, Inc. | 2013-05-24 |
| INTERDRY SILVER (K110715) | Milliken Healthcare Products, LLC | 2011-11-04 |
| INTERDRY TEXTILE WITH SILVER (K061615) | Milliken Chemical | 2006-12-22 |
| CARAPACE STERILE COTTON BALLS (K931626) | Carapace, Inc. | 1993-12-02 |
| ICAN COTTON RAYON BALLS (K914081) | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| TRACH CLEANING TRAY (K811990) | Associated Medical Products Co. | 1981-07-27 |
| UTENSIL & PROCEDURE TRAYS (K810242) | American Hospital Supply Corp. | 1981-04-15 |
| MEDSPEC RAYON BALLS (K800277) | Medspec Corp. | 1980-03-12 |
| SURGITEK FOERSTER FACE LIFT BANDAGE (K800248) | Medical Engineering Corp. | 1980-02-19 |
| SURGITEK FOERSTER MAMMARY BANDAGE (K800249) | Medical Engineering Corp. | 1980-02-19 |
| SORBIES (K792295) | American Hospital Supply Corp. | 1979-12-20 |
| BREAST PAD (K792294) | American Hospital Supply Corp. | 1979-12-11 |
| DEXIDE DISPOSABLE PREP PAD (K791167) | Dexide, Inc. | 1979-08-03 |
| BACILLUS PUMILUS (K780974) | Urol, Inc. | 1978-07-27 |
| CATHETER DRESSING CHANCE SET (K771712) | Shield Laboratories, Inc. | 1977-10-13 |
| I.V. PREP & CARE KIT (K771551) | Jelco Laboratories | 1977-10-04 |
| STERILE COTTON (K770853) | Stat Medical Corp. | 1977-05-23 |
| COTTON BALL KIT (K770588) | American Hospital Supply Corp. | 1977-05-23 |
| DOVER HYPERALIMENTATION DRESSING CHNG KT (K761099) | Will Ross Co. | 1977-01-28 |
Track FRL automatically
Every clearance here is in the API, with alerts when new ones post.