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Patient Ventilation Oxygen Concentrating System, High Flow (PVOCS HF)

by Carleton Life Support Systems, Inc.

510(k) K051887

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051887 Date27 Sep 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
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.

The Patient Ventilation Oxygen Concentrating System, High Flow (PVOCS HF) is a generator of oxygen and portable oxygen device intended to provide respiratory gases, including pre- and post-operative respiratory oxygen, pneumatic drive gas for ventilators and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It is substantially equivalent to a legally marketed device and was cleared through the traditional 510(k) pathway under FDA regulation number 868.5440, with product code CAW and advisory committee classification in Anesthesiology.

The PVOCS HF system is capable of producing up to 30 liters per minute of USP 93% oxygen and 30 liters per minute of medical grade air in high flow mode, and 20 liters per minute of USP 93% oxygen and 75 liters per minute of medical grade air in low flow mode, as verified by non-clinical bench testing. It may be used in military field hospitals and other settings where high-pressure oxygen cylinders or liquid oxygen are not available. The device is supplied by Carleton Life Support Systems, Inc., and its regulatory status is based on FDA 510(k) clearance K051887, with no claims made regarding sterility, single-use or reusable status, MRI safety, storage, or sizes beyond what is explicitly stated in the data.

Other devices from Carleton Life Support Systems, Inc.

Questions

AI-generated answers, 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.

  • What is the PVOCS HF intended for?

    The PVOCS HF is intended to provide respiratory gases, including pre- and post-operative oxygen, pneumatic drive gas for ventilators and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines.

  • What are the oxygen and air flow outputs of the PVOCS HF?

    The PVOCS HF produces up to 30 liters per minute of USP 93% oxygen and 30 liters per minute of medical grade air in high flow mode, and 20 liters per minute of USP 93% oxygen and 75 liters per minute of medical grade air in low flow mode, based on non-clinical bench testing.

  • Where can the PVOCS HF be used?

    The PVOCS HF may be used in military field hospitals and other settings where high-pressure oxygen cylinders or liquid oxygen are not available.