510(k) Report

Devices descending from K153540

4 later devices reach Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.20250—
+1K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.20250—
+1K180139Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd.20191—
+2K242839Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co., Ltd.20240—