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Lifemotion Disposable Membrane Oxygenator

by Lifemotion Medical Technology Co., Ltd. China 510(k)

510(k) K253838 Product code DTZ

Overview

The Lifemotion Disposable Membrane Oxygenator is a single-use gas exchange device that enables extracorporeal blood gas exchange of oxygen and carbon dioxide through gas permeable hollow fibers. It also provides blood temperature control through an integrated heat exchanger.

The device is ethylene oxide sterilized and packaged in a blister pack. It is classified as a Class II medical device with product code DTZ and received FDA 510(k) clearance on March 16, 2026, under the cardiovascular advisory committee.

Summary written by AI from registry data, 28 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253838 Date16 Mar 2026ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Lifemotion Disposable Membrane Oxygenator used for?

    The Lifemotion Disposable Membrane Oxygenator is a single-use device designed for extracorporeal blood gas exchange, enabling oxygen and carbon dioxide exchange through gas permeable hollow fibers. It also provides blood temperature control through an integrated heat exchanger.

  • How is the Lifemotion Disposable Membrane Oxygenator supplied and sterilized?

    The device is ethylene oxide sterilized and packaged in a blister pack for single-use only. This ensures sterility and prevents cross-contamination between patients.

  • What is the regulatory status of the Lifemotion Disposable Membrane Oxygenator?

    The device is classified as a Class II medical device with product code DTZ and received FDA 510(k) clearance on March 16, 2026, under the cardiovascular advisory committee. It is substantially equivalent to predicate devices.

  • Can the Lifemotion Disposable Membrane Oxygenator be reused?

    No, the Lifemotion Disposable Membrane Oxygenator is designed for single-use only. Reusing the device could compromise its sterility and performance, potentially leading to patient safety risks.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K253838 24 fields · synced 22 Oct 2026