510(k) Report

Devices descending from K112805

18 later devices reach Kimguard One-Step Sterilization Wrap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160755Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization WrapAhlstrom Nonwovens, LLC20166—
+1K150698Gemini Sterilization WrapMedline Industries, Inc.20151—
+1K142782KIMGUARD ONE-STEP Sterilization WrapKimberly-Clark Health Care20152—
+1K141712Kimguard One Step Sterilization WrapHalyard Health20145—
+2K223600Sterilization WrapWuhan Zonsen Medical Products Co., Ltd.20230—
+2K192147Halyard ONE-STEP* Sterilization WrapOwens & Minor (O&M) Halyard, Inc.20194—
+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—
+2K162993Gemini Sterilization WrapMedline Industries, Inc.20170—
+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—
+3K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc.20223—
+3K220133Sterilization WrapsWeihai Hongyu Nonwoven Fabric Products Co., Ltd.20220—
+4K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…O&M Halyard, Inc.20242—
+5K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…O&M Halyard, Inc.20260—
+5K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…O&M Halyard, Inc.20260—