Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart G — Miscellaneous](/submissions/AN/subpart-g%E2%80%94miscellaneous) → [21 CFR 868.6885](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6885) → CAM — Yoke Assembly, Medical Gas

# CAM · Yoke Assembly, Medical Gas

_Anesthesiology · 21 CFR 868.6885 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM

## Overview

- **Product Code:** CAM
- **Device Name:** Yoke Assembly, Medical Gas
- **Regulation:** [21 CFR 868.6885](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6885)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply gases for anesthesia or respiratory therapy. The device may include a particulate filter.

## 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K935283](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K935283.md) | YOKE ASSEMBLY MEDICAL GAS | American Gage & Medical, Inc. | Mar 11, 1994 | SESE |
| [K851219](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K851219.md) | FILL HOSE SAFETY ADAPTER | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| [K851217](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K851217.md) | PENOX DUAL FLOW MINIFOLD | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| [K851216](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K851216.md) | PENOX DUAL FEED MANIFOLD | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| [K851215](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K851215.md) | T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER | Penox Technologies, Inc. | Jun 18, 1985 | SESE |
| [K840326](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K840326.md) | GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB | Siemens Elema AB | Jun 7, 1984 | SESE |
| [K780365](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K780365.md) | OXYGEN/NITROUS OXIDE OUTLET | Spica, Inc. | Mar 30, 1978 | SESE |
| [K770426](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM/K770426.md) | OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE | Bel-Med, Inc. | Mar 15, 1977 | SESE |

## Top Applicants

- Penox Technologies, Inc. — 4 clearances
- American Gage & Medical, Inc. — 1 clearance
- Bel-Med, Inc. — 1 clearance
- Siemens Elema AB — 1 clearance
- Spica, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/CAM)

**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
