← Product Code [KMA](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA) · K822351

# POWDER BLOWERS (K822351)

_Kelleher Corp. · KMA · Sep 14, 1982 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K822351

## Device Facts

- **Applicant:** Kelleher Corp.
- **Product Code:** [KMA](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA.md)
- **Decision Date:** Sep 14, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.5550
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K822351](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KMA/K822351)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com