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CPR Bag

by Merced Medical, Inc.

510(k) K911622

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 NumberK911622 Date20 May 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  • Withdrawn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
BTM
Device Class
Class II
Regulation
21 CFR Part 868.5915
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 CPR Bag is a manual emergency ventilator, classified as a Ventilator, Emergency, Manual (Resuscitator), designed to provide assisted ventilation during resuscitation procedures. It functions as a manual resuscitator to deliver positive-pressure ventilation to patients who are not breathing or are breathing inadequately.

The device is supplied by Merced Medical, Inc., and is regulated under product code BTM with a device class of 2. It is intended for use in emergency settings and is associated with the medical specialty of Anesthesiology. The device is subject to FDA 510(k) clearance and was determined to be substantially equivalent under regulation number 868.5915.

Other devices from Merced Medical, Inc.

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 CPR BAG used for?

    The CPR BAG is a manual emergency ventilator designed to provide assisted ventilation during resuscitation procedures. It delivers positive-pressure ventilation to patients who are not breathing or are breathing inadequately in emergency settings.

  • How is the CPR BAG supplied?

    The CPR BAG is supplied by Merced Medical, Inc., located at 113300 A-49th St. N., Clearwater, FL 34622, United States. It is distributed as a complete resuscitator unit intended for immediate emergency use.

  • Is the CPR BAG sterile and single-use?

    The device data does not specify sterility or single-use status. Buyers should consult the manufacturer’s labeling or contact Merced Medical, Inc. directly to confirm whether the unit is supplied sterile, non-sterile, or intended for multiple patient uses with appropriate reprocessing.

  • What regulatory route did the CPR BAG follow?

    The CPR BAG was cleared through the FDA 510(k) premarket notification process under k-number K911622. It was determined substantially equivalent to a predicate device under regulation 868.5915, product code BTM, device class 2.

  • What sizes or models are available?

    The provided device data lists only one model name, CPR BAG, without specifying volume capacities, mask sizes, or interchangeable components. For detailed configuration options, refer to the manufacturer’s technical documentation or contact Merced Medical, Inc. directly.