KNP
7 FDA 510(k) clearances · Product code
24 daysmedian time to decision
46 days90th percentile
7clearances measured
FDA profile
- Official device name
- Orthosis, Corrective Shoe
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1998: 2 · 1999: 1 · 2012: 9 · 2019: 20
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 |
|---|---|---|
| IPOS ANTI-ADDUCTUS SHOE (K831690) | Ipos Luneburg | 1983-06-24 |
| SORBOTHANE VISCO INNER SOLE PAD (K831552) | Fred Sammons, Inc. | 1983-06-08 |
| SLIP-ON SANDALS FOR MEASURING SHORTNESS (K823654) | Fred Sammons, Inc. | 1983-01-21 |
| ROTATION BOOT (K823665) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| SORBOTHANE (K810228) | Hamilton Kent | 1981-02-10 |
| PLASTAZOTE SHOE (K801743) | Alimed, Inc. | 1980-08-07 |
| DRUSHOE (K790326) | J.E. Hanger & Co. , Ltd. | 1979-02-26 |
Track KNP automatically
Every clearance here is in the API, with alerts when new ones post.