510(k) Report

Devices descending from K062704

7 later devices reach Sterilization Pouch with Indicators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112591Safe Secure Sterilization Pounch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd.20126—
+2K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process IndicatorsSafe Secure Packaging Co., Ltd.2016443
+2K143117Wire Sterilization Package with IndicatorsAmerican Orthodontics20150—
+3K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.20250—
+3K243431Medicom Sterilization Pouch and ReelMedicom Asia-Pacific Holdings Ltd. Taiwan Branch.20250—
+3K180139Safe Secure Sterilization Pouches and RollsSafe Secure Packing Co., Ltd.20191—
+4K242839Safe Secure Sterilization Pouches and RollsShenzhen Safesecure Medical Infection Control Tech Co., Ltd.20240—