FDA product code JYM: Inserter, Myringotomy Tube
JYM is the FDA product code for inserter, myringotomy tube. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under JYM, from 3 different applicants. The average 510(k) review took 55 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Inserter, Myringotomy Tube |
| 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 JYM clearance
Top JYM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 2 | 1982-09-13 |
| Exmoor Plastics , Ltd. | 1 | 1993-01-28 |
| Sur-Med Instruments, Inc. | 1 | 1987-03-19 |
Most recent JYM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924901 | Exmoor Plastics , Ltd. | DEANS DISPOSABLE T-TUBE INSERTER | 1993-01-28 | 141 |
| K870978 | Sur-Med Instruments, Inc. | T-TUBE INSERTER | 1987-03-19 | 9 |
| K822349 | Treace Medical, Inc. | ARMSTRONG V TUBE SUCTION INSERTER | 1982-09-13 | 38 |
| K822348 | Treace Medical, Inc. | TYTAN TUBE INSERTER | 1982-09-07 | 32 |
Recalls for JYM devices
openFDA lists no recalls for product code JYM.
Frequently asked questions
What is FDA product code JYM?
JYM is the FDA product code for inserter, myringotomy tube. 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 JYM?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYM?
Across 4 cleared submissions the average was 55 days from receipt to decision (median 35).
Which companies have the most JYM clearances?
Treace Medical, Inc. (2); Exmoor Plastics , Ltd. (1); Sur-Med Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JYM
- Run a recall and safety report across every JYM manufacturer
- Watch product code JYM 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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