Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5450](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5450) → OGG — Humidifier Nebulizer Kit

# OGG · Humidifier Nebulizer Kit

_Anesthesiology · 21 CFR 868.5450 · Class 2_

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

## Overview

- **Product Code:** OGG
- **Device Name:** Humidifier Nebulizer Kit
- **Regulation:** [21 CFR 868.5450](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5450)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

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

**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