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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K260354
Device Name Foster Plus-22L (SNK/CE-F22)
Applicant
Zhejiang Fomos Medical Technology Co., Ltd.
Floor 3 Block 21 #205 Guangyuan Rd.
Jiangbei District Ningbo
Zhejiang,  CN 315033
Applicant Contact My G Tran
Correspondent
Sterling Medical Devices, LLC dba Vantage MedTech
160 Chubb Ave.
Suite 301
Lyndhurst,  NJ  07071
Correspondent Contact Indre Larson
Regulation Number880.6880
Classification Product Code
FLE  
Date Received02/03/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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