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Mobile Pak, Model DC

by Intl. Biomedical Concepts, Inc.

510(k) K880262

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 NumberK880262 Date12 Feb 1988ClearedStatusActive

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  • Withdrawn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 Mobile Pak, Model DC is a portable oxygen generator. It is classified as a class 2 medical device under the anesthesiology medical specialty.

This device is identified by the FDA 510(k) number K880262 and is regulated under 21 CFR 868.5440. It is manufactured by Intl. Biomedical Concepts, Inc.

Other devices from Intl. Biomedical Concepts, 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 Mobile Pak, Model DC used for?

    The Mobile Pak, Model DC is a portable oxygen generator. It is classified under the anesthesiology medical specialty and is regulated under 21 CFR 868.5440.

  • Who is the manufacturer of this device?

    This device is manufactured by Intl. Biomedical Concepts, Inc., located in Englewood, Colorado.

  • What is the regulatory status of the Mobile Pak, Model DC?

    The device is identified by FDA 510(k) number K880262. It was cleared through a traditional 510(k) submission process and is classified as a class 2 medical device.