510(k) Report

Devices descending from K192001

2 later devices reach Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2338143M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™…3M Company20241—
+2K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)3M Company20240—