Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5350](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5350) → BZB — Catheter, Nasal, Oxygen

# BZB · Catheter, Nasal, Oxygen

_Anesthesiology · 21 CFR 868.5350 · Class 1_

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

## Overview

- **Product Code:** BZB
- **Device Name:** Catheter, Nasal, Oxygen
- **Regulation:** [21 CFR 868.5350](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5350)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A nasal oxygen catheter is a device intended to be inserted through a patient's nostril to administer oxygen.

## 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 the limitations in § 868.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K896731](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K896731.md) | OXYGEN CATHETERS | Unoplast A/S | Mar 30, 1990 | SESE |
| [K843466](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K843466.md) | PHARMA-PLAST OXYGEN CATHETER | Zimmar Consulting , Ltd. | Nov 19, 1984 | SESE |
| [K833351](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K833351.md) | DEMAND OXYGEN CONTROLLER | Healthdyne, Inc. | Mar 19, 1984 | SESE |
| [K830984](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K830984.md) | OXYGEN CATHETERS | Medovations, Inc. | May 18, 1983 | SESE |
| [K820370](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K820370.md) | NASAL OXYGEN CATHETER | American Pharmaseal Div. Ahsc | Apr 16, 1982 | SESE |
| [K800506](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K800506.md) | OXYGEN CATHETER | Medi-Craft , Ltd. | Mar 25, 1980 | SESE |
| [K791273](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K791273.md) | CONPHAR OXYGEN CATHETER-STERILE | Conphar, Inc. | Jul 24, 1979 | SESE |
| [K790057](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZB/K790057.md) | CATHETER, OXYGEN | Medline Industries, Inc. | Feb 5, 1979 | SESE |

## Top Applicants

- American Pharmaseal Div. Ahsc — 1 clearance
- Conphar, Inc. — 1 clearance
- Healthdyne, Inc. — 1 clearance
- Medi-Craft , Ltd. — 1 clearance
- Medline Industries, Inc. — 1 clearance

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

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