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Companion Retrofit Oxygen Concentration Indicator

by Puritan Bennett Corp. 510(k)

Active United States

510(k) K920338

Overview

An analyzer, gas, oxygen, gaseous-phase device used to measure oxygen concentration in gaseous phases. It is substantially equivalent to a predicate device and classified under regulation number 868.1720.

The device is supplied by Puritan Bennett Corp. and has received FDA 510(k) clearance under K920338. It is intended for use in anesthesiology settings as indicated by the advisory committee classification.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920338 Date27 Aug 1992ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CCL
Device Class
Class II
Regulation
21 CFR Part 868.1720
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Companion Retrofit Oxygen Concentration Indicator used for?

    It is an analyzer, gas, oxygen, gaseous-phase device used to measure oxygen concentration in gaseous phases, intended for use in anesthesiology settings as indicated by the advisory committee classification.

  • How is the Companion Retrofit Oxygen Concentration Indicator supplied and by whom?

    The device is supplied by Puritan Bennett Corp., located at 9401 Indian Creek Pkwy., P.O. Box 25905, Overland Park, KS 66225, United States.

  • What regulatory pathway was used for the Companion Retrofit Oxygen Concentration Indicator?

    The device received FDA 510(k) clearance under K920338, with a traditional clearance type and a decision date of August 27, 1992, following submission on January 24, 1992.