Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart F — Therapeutic Devices](/submissions/EN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 874.5550](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/874.5550) → KMA — Irrigator, Powered Nasal

# KMA · Irrigator, Powered Nasal

_Ear, Nose, Throat · 21 CFR 874.5550 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA

## Overview

- **Product Code:** KMA
- **Device Name:** Irrigator, Powered Nasal
- **Regulation:** [21 CFR 874.5550](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/874.5550)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## 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](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K140542.md) | NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER | Rhinosystems, Inc. | Jun 27, 2014 | SESE |
| [K973875](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K973875.md) | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM | Respironics, Inc. | Jan 26, 1998 | SESE |
| [K963550](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K963550.md) | RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM | Respironics, Inc. | Nov 1, 1996 | SESE |
| [K950078](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K950078.md) | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | Jun 21, 1995 | SESE |
| [K822351](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K822351.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA)

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