FDA product code KMA: Irrigator, Powered Nasal
KMA is the FDA product code for irrigator, powered nasal. It is a Class I device, regulated under 21 CFR 874.5550 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 5 510(k) submissions under KMA, from 4 different applicants. The average 510(k) review took 96 days (median 108). FDA has posted 1 recall for KMA devices.
Classification
| Field | Value |
|---|---|
| Device name | Irrigator, Powered Nasal |
| Device class | Class I |
| Regulation | 21 CFR 874.5550 |
| 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 KMA clearance
Top KMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Respironics, Inc. | 2 | 1998-01-26 |
| Rhinosystems, Inc. | 1 | 2014-06-27 |
| Jedmed Instrument Co. | 1 | 1995-06-21 |
| Kelleher Corp. | 1 | 1982-09-14 |
Most recent KMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140542 | Rhinosystems, Inc. | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | 2014-06-27 | 115 |
| K973875 | Respironics, Inc. | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM | 1998-01-26 | 108 |
| K963550 | Respironics, Inc. | RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM | 1996-11-01 | 57 |
| K950078 | Jedmed Instrument Co. | MICROFLOW IRRIGATION SYSTEM | 1995-06-21 | 162 |
| K822351 | Kelleher Corp. | POWDER BLOWERS | 1982-09-14 | 39 |
Recalls for KMA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-04-03.
Frequently asked questions
What is FDA product code KMA?
KMA is the FDA product code for irrigator, powered nasal. It is a Class I device, regulated under 21 CFR 874.5550 and reviewed by the Ear, Nose and Throat panel.
What device class is KMA?
Class I, regulation 21 CFR 874.5550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMA?
Across 5 cleared submissions the average was 96 days from receipt to decision (median 108).
Which companies have the most KMA clearances?
Respironics, Inc. (2); Rhinosystems, Inc. (1); Jedmed Instrument Co. (1); Kelleher Corp. (1).
Have KMA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code KMA
- Run a recall and safety report across every KMA manufacturer
- Watch product code KMA 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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