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Trooper Oxygen Concentrator

by Vbox, Inc. 510(k)

Active United States

510(k) K121260

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121260 Date21 Sep 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The device is a Generator, Oxygen, Portable, classified under product code CAW for home-use oxygen therapy and respiratory devices. It is a portable oxygen concentrator designed to deliver oxygen therapy.

It is supplied for prescriptive use by patients requiring oxygen therapy. The device received FDA 510(k) clearance (K121260) as substantially equivalent to predicate devices and is classified as Class II with special controls. It is intended for use in home settings.

Questions

AI-generated answers, 1 Oct 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 Trooper Oxygen Concentrator used for?

    The Trooper Oxygen Concentrator is intended for home-use oxygen therapy, delivering oxygen to patients who require prescribed respiratory support as determined by a healthcare provider.

  • How is the Trooper Oxygen Concentrator supplied and is it reusable?

    The device is supplied for prescriptive use by patients requiring oxygen therapy and is designed as a portable oxygen concentrator for repeated use in home settings, not as a single-use device.

  • What regulatory clearance does the Trooper Oxygen Concentrator have?

    The Trooper Oxygen Concentrator received FDA 510(k) clearance (K121260) as substantially equivalent to predicate devices and is classified as a Class II medical device with special controls.