FDA product code JYJ: Gauge, Measuring
JYJ is the FDA product code for gauge, measuring. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 5 510(k) submissions under JYJ, from 4 different applicants. The average 510(k) review took 135 days (median 114).
Classification
| Field | Value |
|---|---|
| Device name | Gauge, Measuring |
| 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 JYJ clearance
Top JYJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Suredrop, Inc. | 2 | 1989-03-24 |
| Kc Medical Industries | 1 | 1991-06-28 |
| Microtek Medical, Inc. | 1 | 1984-01-03 |
| Aztec Medical Products, Inc. | 1 | 1980-09-09 |
Most recent JYJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904469 | Kc Medical Industries | EYEOPENER | 1991-06-28 | 270 |
| K884974 | Suredrop, Inc. | ACCESSORY TO EYEDROP GUIDE | 1989-03-24 | 114 |
| K874569 | Suredrop, Inc. | SUREDROP EYEDROP GUIDE | 1988-05-03 | 180 |
| K833606 | Microtek Medical, Inc. | IMPLANT MEASURING GAUGE | 1984-01-03 | 83 |
| K801938 | Aztec Medical Products, Inc. | RHINOMETER | 1980-09-09 | 28 |
Recalls for JYJ devices
openFDA lists no recalls for product code JYJ.
Frequently asked questions
What is FDA product code JYJ?
JYJ is the FDA product code for gauge, measuring. 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 JYJ?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYJ?
Across 5 cleared submissions the average was 135 days from receipt to decision (median 114).
Which companies have the most JYJ clearances?
Suredrop, Inc. (2); Kc Medical Industries (1); Microtek Medical, Inc. (1); Aztec Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYJ
- Run a recall and safety report across every JYJ manufacturer
- Watch product code JYJ 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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