Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Lifemotion Disposable Membrane Oxygenator

K-Number: K253838 · 2026-03-16

ApplicantLifemotion Medical Technology Co., Ltd.
Decision Date2026-03-16
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lifemotion Disposable Membrane Oxygenator is the device name listed in this FDA 510(k) record. The listed applicant is Lifemotion Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253838. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lifemotion Disposable Membrane Oxygenator?

Lifemotion Disposable Membrane Oxygenator is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Lifemotion Medical Technology Co., Ltd.. The 510(k) number is K253838.

When did Lifemotion Disposable Membrane Oxygenator receive FDA 510(k) clearance?

Lifemotion Disposable Membrane Oxygenator received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253838.

Who is the listed applicant for Lifemotion Disposable Membrane Oxygenator?

The FDA 510(k) record lists Lifemotion Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lifemotion Disposable Membrane Oxygenator?

The FDA product code for Lifemotion Disposable Membrane Oxygenator is DTZ.

Related Devices (Code: DTZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.LK240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)Medtronic Perfusion SystemsK241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)Medtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑