FDA product code KAR: Irrigator, Sinus
KAR is the FDA product code for irrigator, sinus. 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 KAR, from 3 different applicants. The average 510(k) review took 109 days (median 148).
Classification
| Field | Value |
|---|---|
| Device name | Irrigator, Sinus |
| 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 KAR clearance
Top KAR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hedgepath, LLC | 1 | 2013-09-20 |
| Gm Engineering, Inc. | 1 | 1993-08-30 |
| Jedmed Instrument Co. | 1 | 1986-04-23 |
Most recent KAR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131177 | Hedgepath, LLC | SINUFLUSH LAVAGE SYSTEM | 2013-09-20 | 148 |
| K931398 | Gm Engineering, Inc. | GM SWIVEL VIDEO (TM) IRRIGATOR | 1993-08-30 | 164 |
| K861298 | Jedmed Instrument Co. | FISCH DRILL IRRIGATOR | 1986-04-23 | 16 |
Recalls for KAR devices
openFDA lists no recalls for product code KAR.
Frequently asked questions
What is FDA product code KAR?
KAR is the FDA product code for irrigator, sinus. 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 KAR?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAR?
Across 3 cleared submissions the average was 109 days from receipt to decision (median 148).
Which companies have the most KAR clearances?
Hedgepath, LLC (1); Gm Engineering, Inc. (1); Jedmed Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KAR
- Run a recall and safety report across every KAR manufacturer
- Watch product code KAR 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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