Atlas FDA

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

Steris — Predicate Candidate Screening

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

29 daysmedian FDA review time
214 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
DEN240075Prolystica Pass Thru Disinfectant WipesSteris2026-05-015050
K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP CSteris2025-06-06280
K242773Electro Lube NXTSteris2025-04-152140
DEN230085VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) ISteris2024-11-123300
K242189CELERITY HP Indicator Tape (PCC077)Steris2024-08-20260
K241344MetriCide™ OPA Plus Solution Test StripSteris2024-06-11290
K241055Electro Lube NXTSteris2024-05-31440
K240760CELERITY HP Indicator TapeSteris2024-04-10210
K232826Articulator Injection Needle (00711807), Articulator InjectiSteris2024-03-081770
K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endoSteris2023-12-08240
K233187Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PSteris2023-10-27290
K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris2023-10-20240
K232951BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (0Steris2023-10-20290
K232485AMSCO 600 Steam SterilizerSteris2023-09-13280
K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Steris2023-08-07760
K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature SterSteris2022-09-3090
K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-Steris2022-09-09280
K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Steris2022-09-09560
K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature SterSteris2022-08-2530
K220473CELERITY 20 HP Challenge PackSteris2022-03-18280
K203223Reliance EPS Endoscope Processing System and Reliance DG DrySteris2021-01-28870

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