Skip to content

Manual Pulmonary Resuscitator

by Medical Marketing Concepts

510(k) K953546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK953546 Date29 Feb 1996ClearedStatusActive

Recalls

16 recalls · 1 ongoing · FDA

    • Ongoing Z-1814-2025 FDA Class I initiated 1 May 2025

    Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

  • 14 recalls, same reason

    • Terminated Z-2154-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2148-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2156-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2158-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2147-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2149-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2150-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2153-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2146-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2155-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2152-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2145-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2151-2018 FDA Class II initiated 24 May 2018
    • Terminated Z-2157-2018 FDA Class II initiated 24 May 2018

    There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.

    • Terminated Z-1948-2014 FDA Class I initiated 16 May 2014

    The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Manual Pulmonary Resusicitator
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, 19 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 Manual Pulmonary Resuscitator is a manual emergency ventilator designed to provide artificial ventilation to patients in respiratory distress or cardiac arrest. It delivers controlled breaths to support oxygenation and ventilation when spontaneous respiration is inadequate or absent, serving as a critical tool in resuscitation efforts.

This device is intended for use in clinical settings such as emergency rooms, pre-hospital environments, and operating rooms. Supplied as a reusable medical device, it requires proper cleaning and maintenance between uses. The Manual Pulmonary Resuscitator is classified under product code BTM and has received FDA 510(k) clearance (K953546) as a Class II device under special controls. It is regulated under the regulation number 868.5915 and is intended for use in anesthesiology procedures.

Other devices from Medical Marketing Concepts

See all devices from Medical Marketing Concepts →