Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2700](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2700) → ECX — Cylinder, Compressed Gas, And Valve

# ECX · Cylinder, Compressed Gas, And Valve

_Anesthesiology · 21 CFR 868.2700 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX

## Overview

- **Product Code:** ECX
- **Device Name:** Cylinder, Compressed Gas, And Valve
- **Regulation:** [21 CFR 868.2700](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2700)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

## 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 (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K161179](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K161179.md) | Intelli-Ox | Air Liquide Healthcare America Corporation | Apr 13, 2017 | SESE |
| [K161472](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K161472.md) | Walk-O2-Bout | Essex Industries, Inc. | Nov 18, 2016 | SESE |
| [K153518](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K153518.md) | Medipure Oxygen-LC System | Praxair Distribution, Incorporated. | Jun 3, 2016 | SESE |
| [K143060](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K143060.md) | Intelli-Ox | Air Liquide Healthcare | May 21, 2015 | SESE |
| [K142149](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K142149.md) | OXYTOTE INFINITY SERIES VIPR SYSTEMS | Western/Scott Fetzer Co. | Apr 17, 2015 | SESE |
| [K132778](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K132778.md) | GRAB 'N GO PLUS, GRAB 'N GO DIGITAL | Praxair Healthcare Services | Jul 7, 2014 | SESE |
| [K131386](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K131386.md) | EZ-OX PLUS GENERATION II | Air Liquide Healthcare America | Mar 14, 2014 | SESE |
| [K101792](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K101792.md) | LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 | Linde Gas North America, LLC | Mar 18, 2011 | SESE |
| [K063354](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K063354.md) | LINDE INTEGRATED VALVE (LIV) | Linde Gas Therapeutics | Apr 17, 2007 | SESE |
| [K062300](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K062300.md) | OX-SOX, MODEL C, D, E, | Pattient Safety Innovations, Llp | Nov 27, 2006 | SESE |
| [K053117](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K053117.md) | EZ-OX PLUS | Air Liquide Healthcare America | Apr 10, 2006 | SESE |
| [K033897](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K033897.md) | MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM | Aga-Linde Health Care | Jul 19, 2004 | SESE |
| [K771246](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX/K771246.md) | ALARM SYS FOR NITROUS OXIDE SYS. | Star Dental Mfg. Co. | Jul 15, 1977 | SESE |

## Top Applicants

- Air Liquide Healthcare America — 2 clearances
- Aga-Linde Health Care — 1 clearance
- Air Liquide Healthcare — 1 clearance
- Air Liquide Healthcare America Corporation — 1 clearance
- Essex Industries, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/ECX)

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