FDA product code ILC: Utensil, Eating
ILC is the FDA product code for utensil, eating. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. FDA has cleared 32 510(k) submissions under ILC, from 4 different applicants. The average 510(k) review took 23 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Utensil, Eating |
| 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 ILC clearance
Top ILC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 28 | 1982-12-22 |
| Lic-Orthion | 2 | 1983-04-05 |
| Maddak, Inc. | 1 | 1983-10-31 |
| Techhnilab Instruments, Inc. | 1 | 1977-01-28 |
Most recent ILC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833177 | Maddak, Inc. | GLOSSECTOMY FEEDING SPOONS | 1983-10-31 | 42 |
| K830854 | Lic-Orthion | COLLAPSABLE LAVATORY SEAT HEIGHTENER | 1983-04-05 | 19 |
| K830851 | Lic-Orthion | BATH TUB SEAT & BATH BOARD | 1983-04-05 | 19 |
| K823594 | Fred Sammons, Inc. | PLASTIC BUILT-UP HANDLE EATING UTENSILS | 1982-12-22 | 16 |
| K821643 | Fred Sammons, Inc. | EATING UTENSILS | 1982-06-11 | 8 |
Recalls for ILC devices
openFDA lists no recalls for product code ILC.
Frequently asked questions
What is FDA product code ILC?
ILC is the FDA product code for utensil, eating. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is ILC?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILC?
Across 32 cleared submissions the average was 23 days from receipt to decision (median 17).
Which companies have the most ILC clearances?
Fred Sammons, Inc. (28); Lic-Orthion (2); Maddak, Inc. (1); Techhnilab Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ILC
- Run a recall and safety report across every ILC manufacturer
- Watch product code ILC 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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