510(k) Report

Devices descending from K180672

9 later devices reach Sterilization Pouch/Roll Made with Tyvek through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241123Perpak™ Sterilization Tyvek PouchKm Corp.20240—
+1K221379Steriking LT-Blueline Pouches with TyvekWipak OY20231—
+1K221377SteriKing LT-Blueline Pouches with TyvekWipak OY20221—
+1K212198Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd.20213—
+2K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+2K231996Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+2K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+2K223025Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd.20230—
+2K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—