FDA product code JYO: Knife, Ear
JYO is the FDA product code for knife, 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 7 510(k) submissions under JYO, from 6 different applicants. The average 510(k) review took 71 days (median 82). FDA has posted 1 recall for JYO devices.
Classification
| Field | Value |
|---|---|
| Device name | Knife, 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 JYO clearance
Top JYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 2 | 1978-01-17 |
| Acoustic Imaging Technologies Corp. | 1 | 1991-07-11 |
| Premier Dental Products Co. | 1 | 1984-05-30 |
| Sharpoint, Inc. | 1 | 1984-05-21 |
| Microtek Medical, Inc. | 1 | 1984-01-03 |
1 more applicants have JYO clearances. See the full list in Caduvo.
Most recent JYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910212 | Acoustic Imaging Technologies Corp. | COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST | 1991-07-11 | 177 |
| K841006 | Premier Dental Products Co. | EAR KNIFE-VARIOUS | 1984-05-30 | 82 |
| K840764 | Sharpoint, Inc. | EAR KNIVES | 1984-05-21 | 88 |
| K833602 | Microtek Medical, Inc. | ROLLER KNIFE-TRANSVERSE -SAGITTAL | 1984-01-03 | 83 |
| K823911 | Treace Medical, Inc. | KNIFE BLADE TIP | 1983-01-21 | 24 |
Recalls for JYO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-03-27.
Frequently asked questions
What is FDA product code JYO?
JYO is the FDA product code for knife, 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 JYO?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JYO?
Across 7 cleared submissions the average was 71 days from receipt to decision (median 82).
Which companies have the most JYO clearances?
Edward Weck, Inc. (2); Acoustic Imaging Technologies Corp. (1); Premier Dental Products Co. (1); Sharpoint, Inc. (1); Microtek Medical, Inc. (1).
Have JYO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JYO
- Run a recall and safety report across every JYO manufacturer
- Watch product code JYO 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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