Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5675](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5675) → BYW — Device, Rebreathing

# BYW · Device, Rebreathing

_Anesthesiology · 21 CFR 868.5675 · Class 1_

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

## Overview

- **Product Code:** BYW
- **Device Name:** Device, Rebreathing
- **Regulation:** [21 CFR 868.5675](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5675)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A rebreathing device is a device that enables a patient to rebreathe exhaled gases. It may be used in conjunction with pulmonary function testing or for increasing minute ventilation.

## 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 § 868.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K895274](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYW/K895274.md) | HYPEX | Global Business, Inc. | Feb 23, 1990 | SESE |
| [K802165](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYW/K802165.md) | SHERWOOD VENTILATORY MUSCLE TRAINER | Sherwood Medical Co. | Sep 26, 1980 | SESE |

## Top Applicants

- Global Business, Inc. — 1 clearance
- Sherwood Medical Co. — 1 clearance

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

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