FDA product code ILD: Adaptor, Dressing
ILD is the FDA product code for adaptor, dressing. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. FDA has cleared 14 510(k) submissions under ILD. The average 510(k) review took 19 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Dressing |
| 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 ILD clearance
Top ILD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 14 | 1983-06-08 |
Most recent ILD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831539 | Fred Sammons, Inc. | ECONOMY PLASTIC SOCK-BK2084-AID | 1983-06-08 | 27 |
| K823628 | Fred Sammons, Inc. | LEATHER & VELCRO SHOE FASTENER | 1982-12-28 | 22 |
| K823604 | Fred Sammons, Inc. | ROD W/HOOK TO PULL CLOTHES ON | 1982-12-28 | 22 |
| K823627 | Fred Sammons, Inc. | LEATHER I VELCRO SHOE FASTENER REPAIR | 1982-12-28 | 22 |
| K823603 | Fred Sammons, Inc. | FORMED PLASTIC PANTY HOSE AID | 1982-12-28 | 22 |
Recalls for ILD devices
openFDA lists no recalls for product code ILD.
Frequently asked questions
What is FDA product code ILD?
ILD is the FDA product code for adaptor, dressing. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is ILD?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILD?
Across 14 cleared submissions the average was 19 days from receipt to decision (median 19).
Which companies have the most ILD clearances?
Fred Sammons, Inc. (14).
Next steps
- Run an FDA pathway report with predicate devices for product code ILD
- Run a recall and safety report across every ILD manufacturer
- Watch product code ILD 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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