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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K253838
Device Name Lifemotion Disposable Membrane Oxygenator
Applicant
Lifemotion Medical Technology Co., Ltd.
Bldg. 6, Baoxing Wisdom City
# 650 Zhoushi Rd., Bao’An District District
Shenzhen,  CN 518126
Applicant Contact Giuseppe Tomasini
Correspondent
MEDIcept, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact Melissa DeHass
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/01/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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