KMA
5 FDA 510(k) clearances · Product code
108 daysmedian time to decision
162 days90th percentile
5clearances measured
FDA profile
- Official device name
- Irrigator, Powered Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5550
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER (K140542) | Rhinosystems, Inc. | 2014-06-27 |
| RINOFLOW MICRONIZED E.N.T. WASH SYSTEM (K973875) | Respironics, Inc. | 1998-01-26 |
| RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (K963550) | Respironics, Inc. | 1996-11-01 |
| MICROFLOW IRRIGATION SYSTEM (K950078) | Jedmed Instrument Co. | 1995-06-21 |
| POWDER BLOWERS (K822351) | Kelleher Corp. | 1982-09-14 |
Track KMA automatically
Every clearance here is in the API, with alerts when new ones post.