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Modification Manual Pulmon Resuscitor/Pulmanex(Tm)

by Life Design Systems, Inc.

510(k) K913714

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 NumberK913714 Date1 Dec 1992ClearedStatusActive

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  • Withdrawn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, 1 Oct 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 manual ventilator for emergency resuscitation, classified as a Ventilator, Emergency, Manual (Resuscitator) under FDA device classification. It is a modification of the Pulmanex(TM) resuscitator system, designed for manual ventilation support in emergency settings.

The device received FDA 510(k) clearance K913714 on December 1, 1992, and is classified as a Class II medical device under regulation number 868.5915. It is supplied non-sterile and intended for reuse, with no indication of MRI safety or specific storage requirements provided in the data.

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Questions

AI-generated answers, 1 Oct 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 MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) used for?

    This device is a manual ventilator designed for emergency resuscitation, providing manual ventilation support in emergency settings as a modification of the Pulmanex(TM) resuscitator system.

  • Is the MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) sterile or non-sterile when supplied?

    The device is supplied non-sterile, as indicated in the specifications, and is intended for reuse after appropriate cleaning and disinfection procedures.

  • What regulatory pathway was used for the MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)?

    The device received FDA 510(k) clearance under K913714 on December 1, 1992, and was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.