FDA product code JYK: Holder, Ear Speculum
JYK is the FDA product code for holder, ear speculum. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under JYK. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Holder, Ear Speculum |
| Device class | Class I |
| Regulation | 21 CFR 878.1800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JYK clearance
Top JYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-12 |
Most recent JYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822011 | Kelleher Corp. | SHEA'S EAR SPECULUM HOLDER PORT MANNS | 1982-08-12 | 35 |
Recalls for JYK devices
openFDA lists no recalls for product code JYK.
Frequently asked questions
What is FDA product code JYK?
JYK is the FDA product code for holder, ear speculum. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel.
What device class is JYK?
Class I, regulation 21 CFR 878.1800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYK?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most JYK clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYK
- Run a recall and safety report across every JYK manufacturer
- Watch product code JYK 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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