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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K261719
Device Name Promisemed X-Safety Pen Needle
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
#1388 Cangxing St., Cangqian Community, Yuhang District
Hangzhou,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Promisemed Hangzhou Meditech Co., Ltd.
#1388 Cangxing St., Cangqian Community, Yuhang District
Hangzhou,  CN 311121
Correspondent Contact Zearou Yang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/26/2026
Decision Date 08/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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