FDA product code ILT: Adaptor, Recreational
ILT is the FDA product code for adaptor, recreational. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. FDA has cleared 7 510(k) submissions under ILT. The average 510(k) review took 38 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Recreational |
| 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 ILT clearance
Top ILT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 7 | 1983-01-21 |
Most recent ILT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823656 | Fred Sammons, Inc. | SOFT CATCHER'S MITT | 1983-01-21 | 46 |
| K823657 | Fred Sammons, Inc. | CARD HOLDER FOR QUADS | 1983-01-21 | 46 |
| K781199 | Fred Sammons, Inc. | HOLDER, CARD, QUAD-QUIP | 1978-07-31 | 17 |
| K761116 | Fred Sammons, Inc. | BREATH CONTROL GAME | 1976-12-02 | 13 |
| K760291 | Fred Sammons, Inc. | HOLDER, PENCIL & CRAYON, WITH STAND | 1976-09-08 | 47 |
Recalls for ILT devices
openFDA lists no recalls for product code ILT.
Frequently asked questions
What is FDA product code ILT?
ILT is the FDA product code for adaptor, recreational. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is ILT?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILT?
Across 7 cleared submissions the average was 38 days from receipt to decision (median 46).
Which companies have the most ILT clearances?
Fred Sammons, Inc. (7).
Next steps
- Run an FDA pathway report with predicate devices for product code ILT
- Run a recall and safety report across every ILT manufacturer
- Watch product code ILT 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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