510(k) Report

Devices descending from K092167

35 later devices reach Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC20166—
+1K142782KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care20152—
+1K113806Kimguard One Step Sterilization WrapKimberly-Clark Health Care20139—
+1K110954Arjorad Sterile WrapArjo Wiggins Medical, Inc.20120—
+1K112805Kimguard One-Step Sterilization WrapKimberly-Clark Corp.201218—
+1K112918Durablue Sterilization (Amsco V-Pro) WrapCardinal Health200, LLC201210—
+1K112283Dura Blue Sterilization WrapCardinal Health200, LLC201110—
+2K223600Sterilization WrapWuhan Zonsen Medical Products Co., Ltd.20230—
+2K182656JAMBRO Single Core A Sterilization wrapJiangsu Zhande Medical Supplies Co., Ltd.20191—
+2K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)Owens & Minor Halyard, Inc.20191—
+2K171533Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC20172—
+2K150698Gemini Sterilization WrapMedline Industries, Inc.20151—
+2K141712Kimguard One Step Sterilization WrapHalyard Health20145—
+2K140963Kimguard Smart-Fold Sterilization WrapKimberly-Clark Corp.20140—
+2K141612Kimguard One-Step Sterilization WrapKimberly-Clark Health Care20147—
+2K122507Durablue Sterilization Wrap, Model Numbers CH100, CH200, CH300, CH400, CH500 and CH600…Cardinal Health200, LLC20128—
+2K120658Durablue Sterilization WrapCardinal Health200, LLC20129—
+3K240438CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)Comercializadora Brever20240—
+3K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap…O&M Halyard, Inc.20240—
+3K230137Reliance® Fusion Sterilization WrapsAhlstrom-Munksjo Nonwovens, LLC20230—
+3K220133Sterilization WrapsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20220—
+3K192147Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc.20194—
+3K162993Gemini Sterilization WrapMedline Industries, Inc.20170—
+3K132060Durablue Sterilization WrapCardinal Health-Medical Products and Services20135—
+3K130927Durablue Sterilization WrapCardinal Health200, LLC20130—
+3K123857Durablue Sterilization WrapCardinal Health200, LLC20137—
+4K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc.20223—
+4K151788Cardinal Health Sterilization WrapCardinal Health200, LLC20154—
+5K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…O&M Halyard, Inc.20242—
+5K181174Cardinal Health Sterilization WrapCardinal Health200, LLC20183—
+6K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…O&M Halyard, Inc.20260—
+6K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…O&M Halyard, Inc.20260—
+6K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.20241—
+6K222151Sterilization WrapKenpax International Limited20230—
+7K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc.20240—