KYR
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bag, Ice
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6050
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1994: 2 · 2006: 2
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 |
|---|---|---|
| SAV-A-LIMB (K833872) | Sil-Med Corp. | 1984-02-04 |
| VINYL ICE BAG (K810653) | First Industries, Inc. | 1981-03-27 |
| ICE BAG, VINYL (K780608) | Abco Dealers, Inc. | 1978-06-06 |
| DEVON COOL FACE (K760951) | Devon Industries, Inc. | 1976-12-30 |
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Every clearance here is in the API, with alerts when new ones post.