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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K253044
Device Name RXiBreeze PAP System (RXiBreeze 20C)
Applicant
Resvent Medical Technology Co., Ltd.
Bc601,Gaoxinqi Factory, District 67
Xingdong Community,Xin'An St., Bao'An District
Shenzhen,  CN 518000
Applicant Contact Harry Wang
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Lisa Pritchard
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/22/2025
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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