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) → FOG — Hood, Oxygen, Infant

# FOG · Hood, Oxygen, Infant

_Anesthesiology · 21 CFR 868.5700 · Class 1_

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

## Overview

- **Product Code:** FOG
- **Device Name:** Hood, Oxygen, Infant
- **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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K973128](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K973128.md) | OLYMPUS NA-10J-1 ASPIRATION NEEDLE | Olympus America, Inc. | Nov 18, 1997 | SESE |
| [K962182](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K962182.md) | BURLEW INFANT HOOD | Promedic, Inc. | Jul 15, 1996 | SESE |
| [K955482](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K955482.md) | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) | Advantage Medical Services, Inc. | Jan 30, 1996 | SESE |
| [K830781](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K830781.md) | ENDO-GUARD | Jayco Pharmaceuticals | Mar 31, 1983 | SESE |
| [K792144](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K792144.md) | DISPOSA-HOOD | Utah Medical Products, Inc. | Dec 5, 1979 | SESE |
| [K791861](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K791861.md) | OXYGEN HOODS | Ann Arbor Plastics, Inc. | Oct 4, 1979 | SESE |
| [K790860](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K790860.md) | RT-HOOD | Plastics Supplies & Products | May 29, 1979 | SESE |
| [K780220](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K780220.md) | HOOD, INFANT OXYGEN | Shiley, Inc. | Apr 10, 1978 | SESE |
| [K770754](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K770754.md) | DUODENOSCOPE, MOLEL TX-6 | American Cystocope Makers, Inc. | Apr 28, 1977 | SESE |

## Top Applicants

- Advantage Medical Services, Inc. — 1 clearance
- American Cystocope Makers, Inc. — 1 clearance
- Ann Arbor Plastics, Inc. — 1 clearance
- Jayco Pharmaceuticals — 1 clearance
- Olympus America, Inc. — 1 clearance

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

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