FDA product code JYZ: Rod, Measuring Ear
JYZ is the FDA product code for rod, measuring ear. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under JYZ. The average 510(k) review took 15 days (median 15).
Classification
| Field | Value |
|---|---|
| Device name | Rod, Measuring Ear |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JYZ clearance
Top JYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quinton, Inc. | 1 | 1978-09-14 |
Most recent JYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781500 | Quinton, Inc. | MODEL 845T IMAGING/ERGOMETER TABLE | 1978-09-14 | 15 |
Recalls for JYZ devices
openFDA lists no recalls for product code JYZ.
Frequently asked questions
What is FDA product code JYZ?
JYZ is the FDA product code for rod, measuring ear. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is JYZ?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYZ?
Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).
Which companies have the most JYZ clearances?
Quinton, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYZ
- Run a recall and safety report across every JYZ manufacturer
- Watch product code JYZ 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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