Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Lifemotion Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under approval 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. It is manufactured by Lifemotion Medical Technology Co., Ltd.. The 510(k) number is K253838.

When was Lifemotion Disposable Membrane Oxygenator approved by the FDA?

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

What company makes Lifemotion Disposable Membrane Oxygenator?

Lifemotion Disposable Membrane Oxygenator is manufactured by Lifemotion Medical Technology Co., Ltd..

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)

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium BiosurfaceMedtronic, Inc. K162016Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, Inc. K153295TandemLung OxygenatorCardiacassist, Inc. K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive SurfaceMedtronic, Inc. K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous ReservoirMedtronic, Inc. K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)Terumo Cardiovascular Systems Corporation

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.

↑