KAL
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
146 days90th percentile
5clearances measured
FDA profile
- Official device name
- Retractor, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1999: 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 |
|---|---|---|
| SMALL MASTOID RETRACTOR (K870758) | Treace Medical, Inc. | 1987-03-04 |
| ADJUSTABLE FORK RETRACTOR (K833604) | Microtek Medical, Inc. | 1984-01-03 |
| RING HANDLE & RETRACTORS (K772381) | Edward Weck, Inc. | 1978-01-17 |
| ALLPORT MASTOID RETRACTORS (K772392) | Edward Weck, Inc. | 1978-01-17 |
| CONVERSE ALTAR RETRACTOR (K760851) | V. Mueller O.V. Baxter Healthcare Corp. | 1977-03-10 |
Track KAL automatically
Every clearance here is in the API, with alerts when new ones post.