510(k) Report

Devices descending from K051242

29 later devices reach Winner Self Seal Sterilization Pouch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd.20126—
+1K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp.201116—
+1K110867Steri-Dent, Steri-SureCpac, Inc.20110—
+1K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc.200719—
+1K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd.20077—
+2K212338SterileRight sterilization pouch and rollSterileright Packaging Mfg., Inc.20215—
+2K172280BH Sterilization PouchBh Medical Products Co., Ltd.20181—
+2K180661SIGMA Sterilization Pouch and RollSigma Medical Supplies Corp.20182—
+2K162362PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical IndicatorPms Tibbi Cihazlar Teknolojisi San VE Tic AS20170—
+2K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd.2016443
+2K152669PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std20160—
+2K143117Wire Sterilization Package with IndicatorsAmerican Orthodontics20150—
+2K143637U&U Sterilization Pouch and RollU&U Medical Technology Co, Ltd.20154—
+3K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.20250—
+3K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.20250—
+3K241565Sterilization Package/ReelAnqing Clean Dental Instrument Technology Co., Ltd.20250—
+3K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.20250—
+3K221875Sterilization Pouch and RollQianjiang Kingphar Medical Packaging & Printing Co., Ltd.20233—
+3K191131Solidence MultipocketsSolidence Surgical Corporation20220—
+3K202462SIGMA Sterilization Pouch and RollSigma Medical Supplies Corporation20210—
+3K182184Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch…Mdk (Shanghai) Medical Packing Co., Ltd.20190—
+3K181957Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat…Tianchang Jiarui Packaging Material Co., Ltd.20190—
+3K180139Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd.20191—
+3K162258Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd.20171—
+4K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.20260—
+4K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.20250—
+4K242898Sterilization Pouches and ReelsShanghai Jianzhong Medical Packaging Co., Ltd.20250—
+4K242839Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co., Ltd.20240—
+4K183356Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device…Weihai Xingtai Packaging Products Co., Ltd.20190—