510(k) Report

Devices descending from K002861

3 later devices reach EO Gas Sterilization Process Indicator Tapes, Model CI 124 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240910EO Chex Indicator TapePropper Manufacturing Co., Inc.20240—
+1K210866Steri-Dot Process IndicatorPropper Manufacturing Co., Inc.20211—
+2K241036Autoclave Indicator Tape; EO Indicator TapeJiangmen New Era External Use Drug Co., Ltd.20240—