Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Sterilization Products — Predicate Candidate Screening

54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

196 daysmedian FDA review time
497 days90th percentile
54clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRAdvanced Sterilization Products2024-07-051960
K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, TyvAdvanced Sterilization Products2017-07-312220
K162007STERRAD NX SterilizerAdvanced Sterilization Products2017-02-162110
K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products2016-09-271870
K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products2016-09-261780
K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products2016-01-132011
K151971STERRAD CYCLESURE 24 Biological IndicatorAdvanced Sterilization Products2015-10-291050
K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products2015-04-032132
K140977EVOTECH ECRAdvanced Sterilization Products2014-12-222503
K141693Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products2014-12-191781
K130263STERRAD 50/100S/200 TEST PACKAdvanced Sterilization Products2014-03-284170
K123017STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324Advanced Sterilization Products2012-12-26890
K112087TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLSAdvanced Sterilization Products2012-10-154520
K122044STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATORAdvanced Sterilization Products2012-10-04840
K111519STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202Advanced Sterilization Products2012-10-034890
K111518STERRAD CHEMIAL INDICATOR STRIP MODEL 14100Advanced Sterilization Products2012-10-034890
K111391STERRAD (R) 100NX DUO CYCLE TEST PACKAdvanced Sterilization Products2012-09-264970
K111375STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATORAdvanced Sterilization Products2012-09-144870
K111377STERRAD(R) 100NX STERILIZER DUO CYCLEAdvanced Sterilization Products2012-09-134861
K103210TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAdvanced Sterilization Products2011-06-062170
K103219STERRAD SEALSURE CHEMICAL INDICATOR TAPEAdvanced Sterilization Products2011-04-011510
K103218STERRAD CHEMICAL INDICATOR STRIPAdvanced Sterilization Products2011-04-011510
K092622STERRAD 100NX STERILIZER EXPRESS CYCLEAdvanced Sterilization Products2011-03-045550
K092755STERRAAD 100NX EXPRESS CYCLE TEST PACKAdvanced Sterilization Products2011-02-255340
K103222STERRAD CYCLESURE BIOLOGICAL INDICATORAdvanced Sterilization Products2011-02-251164
K102884STERRAD CYCLESURE 24 BIOLOGICAL INDICATORAdvanced Sterilization Products2011-01-281200
K082392EVOTECH ENDOSCOPE CLEANER AND REPROCESSORAdvanced Sterilization Products2008-11-13863
K071537STERRAD 100NX TEST PACKAdvanced Sterilization Products2007-12-181960
K071385STERRAD 100NX STERILIZERAdvanced Sterilization Products2007-11-291955
K071014MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATORAdvanced Sterilization Products2007-05-24440
K061899EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEMAdvanced Sterilization Products2006-10-261152
K051643STERRAD STERILIZER CYCLESURE TEST PACKAdvanced Sterilization Products2005-08-19600
K042450STERRAD NX CHALLENGE PACKAdvanced Sterilization Products2005-05-122450
K042116STERRAD NX STERILIZERAdvanced Sterilization Products2005-04-2226010
K032959CIDEX OPA CONCENTRATEAdvanced Sterilization Products2005-04-045590
K040883EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEMAdvanced Sterilization Products2005-03-153443
K040742MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPEAdvanced Sterilization Products2004-04-02100
K030429STERRAD 200 STERILIZERAdvanced Sterilization Products2003-08-181898
K031226STERRAD CYCLESURE BIOLOGICAL INDICATORAdvanced Sterilization Products2003-05-02141
K023290STERRAD 50 & STERRAD 100S STERILIZERSAdvanced Sterilization Products2003-04-031839
K0300040.55% ORTH-PHTHALALDEHYDE SOLUTIONAdvanced Sterilization Products2003-02-27562
K022441STERRAD SEALSURE CHEMICAL INDICATOR TAPEAdvanced Sterilization Products2002-10-08750
K013003APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDEAdvanced Sterilization Products2002-08-283560
K994055STERRAD CYCLESURE BIOLOGICAL INDICATORAdvanced Sterilization Products2002-02-138061
K002401CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)Advanced Sterilization Products2000-08-29221
K991999STERRAD 100S STERILIZERAdvanced Sterilization Products2000-06-153676
K993775STERRAD BI TEST PACKAdvanced Sterilization Products2000-06-012060
K001381CIDEX OPA SOLUTIONAdvanced Sterilization Products2000-05-17150
K991487CIDEX OPA SOLUTIONAdvanced Sterilization Products1999-10-081630
K991675MODIFICATION OF: STERRAD BI TEST PACKAdvanced Sterilization Products1999-06-15290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda