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COPD Liquid Oxygen Portable, Model 300P

by Copd Partners, Inc.

510(k) K072011

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072011 Date18 Oct 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BYJ
Device Class
Class II
Regulation
21 CFR Part 868.5655
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A COPD Liquid Oxygen Portable, Model 300P is a unit, liquid-oxygen, portable device intended to provide a source of supplemental oxygen for ambulatory home healthcare patients by vaporizing medical liquid oxygen. It consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, an electronic printed circuit board (PCB), an oxygen conserving system, and a protective case, with a Dewar capacity to store 0.33 liters of liquid oxygen.

The device is supplied as a portable unit for use in home healthcare settings. It is a reusable device that requires refilling with liquid oxygen. Regulatory information indicates it received FDA 510(k) clearance (K072011) on October 18, 2007, and is classified as a Class II device under regulation number 868.5655 with product code BYJ.

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