510(k) Report

Devices descending from K926364

35 later devices reach Attest Brand Rapid Readout Biological Ind. #129X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical20170—
+1K1214843M Attest (TM) Super Rapid Readout Biological Indicator, 3M Attest (TM) Auto-Reader3M Company201231—
+1K090569Modification to: Attest Rapid Readout Biological Indicator, Mode 12923M Company200934—
+2K1734373M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M…3M Company201851
+2K173634CELERITY 20 Steam Biological IndicatorSTERIS Corporation20182—
+2K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc.20160—
+2K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company201412—
+2K1215933M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5…3M Company201311—
+3K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490…3M Company20240—
+3K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid…3M Company20202—
+3K200126VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation20200—
+3K2000923MTM AttestTM Mini Auto-reader 490M3M20200—
+3K181686CELERITY 20 Steam Biological IndicatorSTERIS Corporation20180—
+3K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus…3M Company201871
+3K173626Celerity 20 Steam Process Challenge Device for Dynamic Air Removal CyclesSTERIS Corporation201801
+3K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company20175—
+3K170039STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp)20173—
+3K170070VERIFY ASSERT STEAM Process Challenge Device for Gravity CyclesSTERIS Corporation20171—
+3K1520603M Attest Rapid Readout Biological Indicator 12953M Company201511—
+4K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge…3M Company20221—
+4K1931543M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company202032
+4K182404STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp)20182—
+4K173629CELERITY 20 Steam Process Challenge Device for Gravity CyclesSTERIS Corporation20180—
+4K1734353M Attest Rapid Readout Biological Indicator3M Company20184—
+4K1605463M Attest Rapid Readout Biological Indicator3M Company20166—
+5K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam…3M Company20240—
+5K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader…3M Company20240—
+5K2009963M Attest Rapid Readout Biological Indicator3M Company20203—
+5K2007663M Attest Steam Chemical Integrator Test Pack3M Company20200—
+5K2005363MTM AttestTM Rapid 5 Steam-Plus Test Pack3M Complany20200—
+5K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderAdvanced Sterilization Products (Asp)20201—
+6K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…Advanced Sterilization Products, Inc.20240—
+6K2102773M Attest Rapid Readout Biological Indicator, 12953M Company20212—
+7K2117053M Attest Rapid Readout Biological Indicator, 12953M Company20221—
+8K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen…3M Company20240—