FDA product code IKW: Utensil, Homemaking
IKW is the FDA product code for utensil, homemaking. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. FDA has cleared 12 510(k) submissions under IKW. The average 510(k) review took 21 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Utensil, Homemaking |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IKW clearance
Top IKW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 12 | 1983-06-08 |
Most recent IKW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831545 | Fred Sammons, Inc. | REACHER & DOOR OPENER | 1983-06-08 | 27 |
| K823607 | Fred Sammons, Inc. | CARPET SWEEPER | 1982-12-28 | 22 |
| K823633 | Fred Sammons, Inc. | TURNERS FOR KNOBS | 1982-12-28 | 22 |
| K823605 | Fred Sammons, Inc. | PORTABLE ELECTRIC CAN OPENER | 1982-12-28 | 22 |
| K821646 | Fred Sammons, Inc. | TINY FLEX-GLASS, SET OF 4 | 1982-06-11 | 8 |
Recalls for IKW devices
openFDA lists no recalls for product code IKW.
Frequently asked questions
What is FDA product code IKW?
IKW is the FDA product code for utensil, homemaking. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is IKW?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IKW?
Across 12 cleared submissions the average was 21 days from receipt to decision (median 22).
Which companies have the most IKW clearances?
Fred Sammons, Inc. (12).
Next steps
- Run an FDA pathway report with predicate devices for product code IKW
- Run a recall and safety report across every IKW manufacturer
- Watch product code IKW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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