510(k) Report

Devices descending from K951295

28 later devices reach Sterrad Sterilization Pouch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103210Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…Advanced Sterilization Products201115—
+1K071087Vis-U-All II Heat-Seal Pouch and TubingSTERIS Corporation200711—
+2K133838Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp.201510—
+2K123162U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollU&U Medical Technology Co, Ltd.20140—
+2K112087Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsAdvanced Sterilization Products20122—
+2K092745Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and…STERIS Corporation201011
+2K090371Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization SystemSTERIS Corporation20099—
+3K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—
+3K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation20189—
+3K141693Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products201411
+3K140487Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20148—
+4K241123Perpak™ Sterilization Tyvek PouchKm Corp.20240—
+4K221379Steriking LT-Blueline Pouches with TyvekWipak OY20231—
+4K221377SteriKing LT-Blueline Pouches with TyvekWipak OY20221—
+4K212198Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd.20213—
+4K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…Advanced Sterilization Products20170—
+4K160595PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical IndicatorPms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti20160—
+4K160908Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20166—
+5K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+5K231996Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+5K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+5K223025Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd.20230—
+5K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+5K172749Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20185—
+6K183401Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20193—
+6K183297Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation20190—
+7K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+8K231501PRO-LITE Sterilization TraySTERIS Corporation20230—