510(k) Report

Devices descending from K112057

31 later devices reach KDL Syringes and Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231729Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd.20230—
+1K211211Sterile syringes for single use with/without needleAzur Medical Company, Inc.20211—
+1K210227Sterile syringe for single use with/without needleZhejiang Kangkang Medical-Devices Co., Ltd.20212—
+1K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd.201913—
+1K170218Vesco Medical NRFit Tip SyringesVesco Medical, LLC20174—
+1K153537Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc.20165—
+2K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleCMT Health PTE., Ltd.20250—
+2K220713Sol-Guard Auto-disable SyringeSol-Millennium Medical, Inc.20230—
+2K212207Sterile Hypodermic Syringe for Single UseShandong Weigao Group Medical Polymer Co., Ltd.20230—
+2K212635SofjecHwajin Medical Co., Ltd.20232—
+2K212846Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic…Jiangsu Jichun Medical Devices Co., Ltd.20220—
+2K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin…Shandong Zhushi Pharmaceutical Group Co., Ltd.20220—
+2K213811Sterile Hypodermic Syringes for Single UseBerpu Medical Technology Co., Ltd.20221—
+2K201044CHIRANA Insulin SyringesChirana T. Injecta20221—
+2K212226DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd.20210—
+2K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesPromisemed Hangzhou Meditech Co., Ltd.20213—
+2K201930Nanum SyringeNanum Company Co., Ltd.20210—
+2K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile…Set Medikal Sanayi VE Ticaret Anonim Sirketi20202—
+2K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial…Top Corporation20190—
+2K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd20180—
+2K171131MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC20171—
+3K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.20260—
+3K242434Insulin SyringesChirana T. Injecta20240—
+3K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20241—
+3K212857Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single UseJiangsu Zhiyu Medical Instrument Co, Ltd.20230—
+3K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd.20220—
+3K213560Verifine Safety Syringe with Fixed NeedlePromisemed Hangzhou Meditech Co., Ltd.20222—
+3K2102001 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-LockSet Medikal Sanayi VE Ticaret Anonim Sirketi20210—
+4K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20260—
+4K231792VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd.20231—
+5K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.20250—