KMA · Irrigator, Powered Nasal
Ear, Nose, Throat · 21 CFR 874.5550 · Class 1
Overview
| Product Code | KMA |
|---|---|
| Device Name | Irrigator, Powered Nasal |
| Regulation | 21 CFR 874.5550 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140542 | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | Rhinosystems, Inc. | Jun 27, 2014 | SESE |
| K973875 | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM | Respironics, Inc. | Jan 26, 1998 | SESE |
| K963550 | RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM | Respironics, Inc. | Nov 1, 1996 | SESE |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | Jun 21, 1995 | SESE |
| K822351 | POWDER BLOWERS | Kelleher Corp. | Sep 14, 1982 | SESE |
Top Applicants
- Respironics, Inc. — 2 clearances
- Jedmed Instrument Co. — 1 clearance
- Kelleher Corp. — 1 clearance
- Rhinosystems, Inc. — 1 clearance
