IKW
12 FDA 510(k) clearances · Product code
22 daysmedian time to decision
27 days90th percentile
12clearances measured
FDA profile
- Official device name
- Utensil, Homemaking
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5050
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1997: 1 · 1998: 1 · 1999: 1 · 2001: 5 · 2002: 1
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 |
|---|---|---|
| REACHER & DOOR OPENER (K831545) | Fred Sammons, Inc. | 1983-06-08 |
| PORTABLE ELECTRIC CAN OPENER (K823605) | Fred Sammons, Inc. | 1982-12-28 |
| CARPET SWEEPER (K823607) | Fred Sammons, Inc. | 1982-12-28 |
| TURNERS FOR KNOBS (K823633) | Fred Sammons, Inc. | 1982-12-28 |
| TINY FLEX-GLASS, SET OF 4 (K821646) | Fred Sammons, Inc. | 1982-06-11 |
| JAR HOLDER & OPENER (K813631) | Fred Sammons, Inc. | 1982-01-19 |
| HOMEMAKING UTENSILS (K810454) | Fred Sammons, Inc. | 1981-03-04 |
| BK-5371 GAD-19-BOUT PERSONAL MOBIL AID (K790173) | Fred Sammons, Inc. | 1979-02-22 |
| PRUNING SCISSORS (K761122) | Fred Sammons, Inc. | 1976-12-02 |
| ROLLING PIN (K761115) | Fred Sammons, Inc. | 1976-12-02 |
| WEED PULLER & PRUNER (K761124) | Fred Sammons, Inc. | 1976-12-02 |
| LEVERS, DOOR KNOB, BK-6395 (K760294) | Fred Sammons, Inc. | 1976-09-08 |
Track IKW automatically
Every clearance here is in the API, with alerts when new ones post.