510(k) Report

Devices descending from K013228

14 later devices reach 3M Comply 1248 Gas Plasma Chemical Indicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1506223M Comply Hydrogen Peroxide Chemical Indicator 12483M Company201513—
+2K1703213M Comply Hydrogen Peroxide Chemical Indicator 12483M Company201712—
+3K1832113M Comply Hydrogen Peroxide Chemical Indicator3M Company201911—
+4K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Healthcare202071
+4K1929373M Comply Hydrogen Peroxide Chemical Indicator3M Company20192—
+5K2034583M Comply Hydrogen Peroxide Chemical Indicator 12483M Company20201—
+5K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company20206—
+6K2225083M™ Comply™ Hydrogen Peroxide Chemical Indicator 12483M Company20220—
+6K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company20221—
+6K213262CELERITY HP Chemical IndicatorSTERIS Corporation20223—
+7K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen…3M Company20240—
+7K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris20232—
+8K240760CELERITY HP Indicator TapeSteris20241—
+9K242189CELERITY HP Indicator Tape (PCC077)Steris20240—