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Puritan Bennett Companion 550 Liquid Oxygen Portable Unit

by Puritan Bennett Corp.

510(k) K933930

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 NumberK933930 Date21 Mar 1994ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

The Puritan Bennett Companion 550 Liquid Oxygen Portable Unit is a portable, thermally insulated container of liquid oxygen intended to supplement gases to be inhaled by a patient. It is part of a liquid oxygen system that includes both stationary and portable units for oxygen storage and delivery.

This portable unit is designed to be filled from a stationary liquid oxygen reservoir and is supplied with tubing and an oxygen mask for patient use. The device is a Class II medical product with FDA 510K clearance (K933930) and is regulated under product code BYJ for anesthesiology applications.

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Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit used for?

    The Puritan Bennett Companion 550 is a portable, thermally insulated container of liquid oxygen designed to supplement gases to be inhaled by patients. It is part of a liquid oxygen system that includes both stationary and portable units for oxygen storage and delivery.

  • How is the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit supplied?

    The portable unit is designed to be filled from a stationary liquid oxygen reservoir and is supplied with tubing and an oxygen mask for patient use, making it convenient for oxygen therapy outside of a clinical setting.

  • What is the regulatory status of the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit?

    The device is a Class II medical product with FDA 510K clearance (K933930) and is regulated under product code BYJ for anesthesiology applications. It received FDA clearance on March 21, 1994.

  • Can the Puritan Bennett Companion 550 Liquid Oxygen Portable Unit be reused?

    The device is designed as a portable unit that can be filled from a stationary reservoir, allowing for multiple uses. However, specific reuse instructions would depend on the manufacturer's guidelines and proper maintenance procedures.