Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5560](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5560) → BTK — Strap, Head, Gas Mask

# BTK · Strap, Head, Gas Mask

_Anesthesiology · 21 CFR 868.5560 · Class 1_

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

## Overview

- **Product Code:** BTK
- **Device Name:** Strap, Head, Gas Mask
- **Regulation:** [21 CFR 868.5560](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5560)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.

## 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K944949](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K944949.md) | GENERAL ANESTHESIA SYSTEM | Vital Signs, Inc. | Nov 14, 1994 | SESK |
| [K914335](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K914335.md) | STRAP, HEAD, GAS MASK | Vital Signs, Inc. | Apr 2, 1992 | SESE |
| [K854537](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K854537.md) | HEADSTRAP | Life Design Systems, Inc. | Dec 3, 1985 | SESE |
| [K853573](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K853573.md) | MEDIPART FACE MASK HEADSTRAP MP-9100 | Medipart Jerry Alexander | Oct 29, 1985 | SESE |
| [K831008](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K831008.md) | HEAD STRAP | Medovations, Inc. | May 9, 1983 | SESE |
| [K810991](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K810991.md) | HEADSTRAP | Respironics, Inc. | Apr 29, 1981 | SESE |

## Top Applicants

- Vital Signs, Inc. — 2 clearances
- Life Design Systems, Inc. — 1 clearance
- Medipart Jerry Alexander — 1 clearance
- Medovations, Inc. — 1 clearance
- Respironics, Inc. — 1 clearance

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

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