Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5700](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5700) → BYL — Tent, Oxygen

# BYL · Tent, Oxygen

_Anesthesiology · 21 CFR 868.5700 · Class 1_

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

## Overview

- **Product Code:** BYL
- **Device Name:** Tent, Oxygen
- **Regulation:** [21 CFR 868.5700](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5700)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K935126](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K935126.md) | NASCOR IGLOO | Nascor Pty. , Ltd. | Oct 18, 1994 | SESE |
| [K905627](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K905627.md) | NASCOR OXYDOME | Nascor Pty. , Ltd. | Jun 3, 1991 | SESE |
| [K896608](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K896608.md) | SPAG PAK | Viratek, Inc. | Apr 9, 1990 | SESE |
| [K895866](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K895866.md) | DIRD INGANT O2 (BIO 2 HOOD) | Bird Products Corp. | Oct 27, 1989 | SESE |
| [K893714](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K893714.md) | KEYSTONE OXYGEN TENT | Keystone Veterinary Supplies, Inc. | Aug 21, 1989 | SESE |
| [K893713](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K893713.md) | NOVA OXYGEN TENT | Nova Health Systems, Inc. | Aug 21, 1989 | SESE |
| [K882396](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K882396.md) | AEROSOL DELIVERY HOOD | Viratek, Inc. | Aug 1, 1988 | SESE |
| [K851666](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K851666.md) | MEDI-COMP NEONATAL OXYGEN HOOD | Medicomp, Inc. | Aug 6, 1985 | SESE |
| [K852345](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K852345.md) | SEA-LONG NECKSEAL & HOOD | Safety Sea Systems, Inc. | Jun 20, 1985 | SESE |
| [K820640](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K820640.md) | HOO2D SEAT-INFANT | Dhd Medical Products Div. Diemolding Corp. | Mar 26, 1982 | SESE |
| [K802653](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYL/K802653.md) | MEDIUM SIZE OXYGEN HOOD #1547 | Ann Arbor Plastics, Inc. | Nov 24, 1980 | SESE |

## Top Applicants

- Nascor Pty. , Ltd. — 2 clearances
- Viratek, Inc. — 2 clearances
- Ann Arbor Plastics, Inc. — 1 clearance
- Bird Products Corp. — 1 clearance
- Dhd Medical Products Div. Diemolding Corp. — 1 clearance

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

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