Atlas FDA

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

STERIS Corporation — Predicate Candidate Screening

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

96 daysmedian FDA review time
230 days90th percentile
205clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261055AMSCO 700 Steam SterilizerSTERIS Corporation2026-06-24850
K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, ModelSTERIS Corporation2026-04-083130
K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation2026-04-08300
K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation2025-09-24300
K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # =STERIS Corporation2025-05-02290
K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation2025-04-251280
K250842PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation2025-04-18290
K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP CSTERIS Corporation2025-02-06270
K250061Celerity IncubatorSTERIS Corporation2025-02-06270
K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation2024-12-04260
K243433enspire 3000 Cleaning and Liquid Chemical Sterilant ProcessiSTERIS Corporation2024-12-02270
K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (STERIS Corporation2024-11-08420
K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS ESTERIS Corporation2024-10-11300
K240274PADLOCK CLIP EFTR Kit (00713229)STERIS Corporation2024-09-172300
K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation2024-04-171040
K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation2024-03-06300
K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS ESTERIS Corporation2024-02-09280
K233681ConFirm 20 Minute IncubatorSTERIS Corporation2023-12-15290
K233682VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATESTERIS Corporation2023-12-15290
K232918enspire 300 Series Automated Endoscope ReprocessorSTERIS Corporation2023-10-03140
K232914SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500STERIS Corporation2023-10-03140
K231746VERIFY Spore Test Strip for S40 Sterilant ConcentrateSTERIS Corporation2023-09-11880
K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-ContainSTERIS Corporation2023-08-07760
K223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation2023-08-072620
K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation2023-08-07750
K231501PRO-LITE Sterilization TraySTERIS Corporation2023-08-07750
K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard STERIS Corporation2023-07-25290
K230560enspire 300 Series Automated Endoscope Reprocessor SystemSTERIS Corporation2023-07-211430
K230558Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation2023-07-171390
K230930enspire 3000 Cleaning and Liquid Chemical Sterile ProcessingSTERIS Corporation2023-06-30880
K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge STERIS Corporation2023-06-151850
K223715Celerity IncubatorSTERIS Corporation2023-06-151950
K230582SYSTEM 1 endo Liquid Chemical Sterilant Processing System, MSTERIS Corporation2023-03-28260
K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard STERIS Corporation2023-02-17920
K223369truFreeze Console, PN CC301; Aire PV Passive Venting CatheteSTERIS Corporation2022-12-02280
K222615SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTESTERIS Corporation2022-09-28290
K222272truFreeze Console, PN CC301; Aire PV Passive Venting CatheteSTERIS Corporation2022-08-18200
K213881Celerity IncubatorSTERIS Corporation2022-07-212200
K220395EndoGator Endoscopy Irrigation TubingSTERIS Corporation2022-03-11280
K220361Reliance EPS Endoscope Processing System and Reliance DG DrySTERIS Corporation2022-03-10300
K213262CELERITY HP Chemical IndicatorSTERIS Corporation2022-01-07990
K211347Uretero1 Ureteroscope SystemSTERIS Corporation2021-11-232040
K212424AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam StSTERIS Corporation2021-10-28850
K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmaSTERIS Corporation2021-10-07290
K211607SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTESTERIS Corporation2021-09-071050
K210342BioShield- ERCP Biopsy Valve, BioShield Irrigator - ExtensioSTERIS Corporation2021-09-032100
K211500AMSCO 600 Medium Steam SterilizerSTERIS Corporation2021-08-251030
K210737SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTESTERIS Corporation2021-05-12620
K202104BioGuard EUS Air/Water and Suction ValvesSTERIS Corporation2021-01-141690
K202721Celerity 20 Steam Biological Indicator for IUSSSTERIS Corporation2021-01-081130

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