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CONTEMPRO2 Home Health Care Regulator

by Continental Products, Inc.

510(k) K913327

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 NumberK913327 Date20 Dec 1991ClearedStatusActive

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  • Withdrawn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, 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.

This device is a Generator, Oxygen, Portable, classified under device class 2. It is identified by the product code CAW and regulation number 868.5440.

The device received FDA 510(k) clearance under K913327 on December 20, 1991, as substantially equivalent. It is manufactured by Continental Products, Inc. and is intended for use in home health care settings.

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 CONTEMPRO2 HOME HEALTH CARE REGULATOR used for?

    It is a portable oxygen generator intended for use in home health care settings to provide supplemental oxygen therapy, as indicated by its FDA 510(k) clearance and device classification as a Generator, Oxygen, Portable.

  • How is the CONTEMPRO2 HOME HEALTH CARE REGULATOR supplied and is it reusable?

    The device is supplied as a portable oxygen generator for home use; however, the provided data does not specify whether it is single-use or reusable, so reuse status cannot be determined from the available information.

  • What regulatory pathway was used for the CONTEMPRO2 HOME HEALTH CARE REGULATOR?

    It received FDA 510(k) clearance under K913327 on December 20, 1991, as substantially equivalent to a legally marketed predicate device, following a traditional review process.