510(k) Report

Devices descending from K192147

4 later devices reach Halyard ONE-STEP* Sterilization Wrap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapOwens & Minor (O&M) Halyard, Inc.20223—
+2K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap…O&M Halyard, Inc.20242—
+3K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…O&M Halyard, Inc.20260—
+3K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…O&M Halyard, Inc.20260—