FDA product code JYS: Perforator, Ear-Lobe
JYS is the FDA product code for perforator, ear-lobe. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under JYS, from 3 different applicants. The average 510(k) review took 157 days (median 185).
Classification
| Field | Value |
|---|---|
| Device name | Perforator, Ear-Lobe |
| 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 JYS clearance
Top JYS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Onyx Industries, Inc. | 1 | 1986-10-17 |
| Jay Kenny Templeton | 1 | 1986-08-29 |
| Robert C. Cameron | 1 | 1978-01-03 |
Most recent JYS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860622 | Onyx Industries, Inc. | STUDEX EAR PIERCING GUNS | 1986-10-17 | 240 |
| K860678 | Jay Kenny Templeton | J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS | 1986-08-29 | 185 |
| K772171 | Robert C. Cameron | EAR PIERCING DEVICE | 1978-01-03 | 46 |
Recalls for JYS devices
openFDA lists no recalls for product code JYS.
Frequently asked questions
What is FDA product code JYS?
JYS is the FDA product code for perforator, ear-lobe. 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 JYS?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYS?
Across 3 cleared submissions the average was 157 days from receipt to decision (median 185).
Which companies have the most JYS clearances?
Onyx Industries, Inc. (1); Jay Kenny Templeton (1); Robert C. Cameron (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYS
- Run a recall and safety report across every JYS manufacturer
- Watch product code JYS 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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