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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K254289
Device Name Portable Oxygen Concentrator (OX-1A-E, OX-1B)
Applicant
Oxytek Medical Technology Co., Ltd.
Rm. 801, 802, Bldg. 8, Cimc High Tech Intelligent
Manufacturing Center, # 3 Chanxing 1st Rd., Xianchong Vil
Chencun Town, Shunde District, Foshan,  CN 528313
Applicant Contact Jenny Liu
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou,  CN 51000
Correspondent Contact Cassie Lee
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/31/2025
Decision Date 09/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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