Atlas FDA

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

Sterilucent, Inc. — Predicate Candidate Screening

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

169 daysmedian FDA review time
254 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192001Sterilucent self-Contained Biological Indicator, SterilucentSterilucent, Inc.2019-10-22880
K191999Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc.2019-10-21870
K190005Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc.2019-09-132540
K142109STERILUCENT STERILIZATION CONTAINER SYSTEMSterilucent, Inc.2015-01-201690
K141238STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATORSterilucent, Inc.2014-11-031740
K141312STERILUCENT PROCESS CHALLENGE DEVICESterilucent, Inc.2014-10-311640
K140464STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZERSterilucent, Inc.2014-10-312490

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