Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5710](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5710) → BYK — Tent, Oxygen, Electrically Powered

# BYK · Tent, Oxygen, Electrically Powered

_Anesthesiology · 21 CFR 868.5710 · Class 2_

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

## Overview

- **Product Code:** BYK
- **Device Name:** Tent, Oxygen, Electrically Powered
- **Regulation:** [21 CFR 868.5710](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5710)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Life-sustaining:** yes

## Identification

An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K941547](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK/K941547.md) | CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT | Allied Healthcare Products, Inc. | Mar 1, 1995 | SESE |
| [K882817](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK/K882817.md) | LUNG DIFFUSION GAS MIXTURE | Swisco, Inc. | Aug 15, 1988 | SESE |
| [K813235](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK/K813235.md) | DISS FEMALE AIR ADAPTOR | Timeter Instrument Corp. | Dec 8, 1981 | SESE |

## Top Applicants

- Allied Healthcare Products, Inc. — 1 clearance
- Swisco, Inc. — 1 clearance
- Timeter Instrument Corp. — 1 clearance

---

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

**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