FDA product code LEY: Set, Oral Administration
LEY is the FDA product code for set, oral administration. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under LEY. The average 510(k) review took 58 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Set, Oral Administration |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | HO — General Hospital |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LEY clearance
Top LEY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cis Radiopharmaceuticals, Inc. | 1 | 1976-09-15 |
Most recent LEY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760251 | Cis Radiopharmaceuticals, Inc. | SET, ORAL ADMINISTRATION | 1976-09-15 | 58 |
Recalls for LEY devices
openFDA lists no recalls for product code LEY.
Frequently asked questions
What is FDA product code LEY?
LEY is the FDA product code for set, oral administration. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the General Hospital panel.
What device class is LEY?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code LEY?
Across 1 cleared submissions the average was 58 days from receipt to decision (median 58).
Which companies have the most LEY clearances?
Cis Radiopharmaceuticals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LEY
- Run a recall and safety report across every LEY manufacturer
- Watch product code LEY 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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