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Oxygen Supply Control Regulator (OSCR)

by Transamerica Products, Inc.

510(k) K874804

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 NumberK874804 Date11 Feb 1988ClearedStatusActive

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  • Withdrawn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
NFB
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Oxygen Supply Control Regulator (OSCR) is an oxygen conserver device designed to regulate the delivery of oxygen. It functions as a medical device within the anesthesiology specialty to manage oxygen supply flow.

This device is identified by FDA 510(k) clearance number K874804. It is classified as a class 2 medical device under regulation number 868.5905.

Questions

AI-generated answers, 21 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 primary function of the Oxygen Supply Control Regulator?

    The Oxygen Supply Control Regulator is an oxygen conserver device specifically designed to regulate the delivery of oxygen flow for patients within the anesthesiology specialty.

  • What is the regulatory status of the OSCR device?

    The Oxygen Supply Control Regulator has received FDA 510(k) clearance under the number K874804 and is classified as a class 2 medical device under regulation number 868.5905.

  • Which medical specialty is this device intended for?

    This device is intended for use within the anesthesiology specialty, as it is classified under the anesthesiology advisory committee for the management of oxygen supply.