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) → OBN — Humidifier, Respiratory, Mask (Direct Patient Interface)

# OBN · Humidifier, Respiratory, Mask (Direct Patient Interface)

_Anesthesiology · 21 CFR 868.5450 · Class 2_

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

## Overview

- **Product Code:** OBN
- **Device Name:** Humidifier, Respiratory, Mask (Direct Patient Interface)
- **Regulation:** [21 CFR 868.5450](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5450)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K070467](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/OBN/K070467.md) | HEALTH MASK | Polar Wrap, LLC | Apr 17, 2007 | SESE |

## Top Applicants

- Polar Wrap, LLC — 1 clearance

---

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

**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