Atlas FDA

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

Tso3, Inc. — Predicate Candidate Screening

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

190 daysmedian FDA review time
405 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190260STERIZONE(R) VP4 SterilizerTso3, Inc.2019-07-191610
K172191STERIZONE VP4 SterilizerTso3, Inc.2018-05-092930
K173694STERIZONE VP4 SterilizerTso3, Inc.2018-03-131020
K153689STERIZONE SterilizerTso3, Inc.2016-06-301900
K141698STERIZONE CHEMICAL INDICATORTso3, Inc.2014-12-171760
K141580STERIZONE SELF-CONTAINED BIOLOGICAL INDICATORTso3, Inc.2014-12-171870
K141163STERIZONE STERILIZERTso3, Inc.2014-12-172260
K090636TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.2009-12-022670
K080198TSO3 OZONE STERILIZATION WRAPTso3, Inc.2008-05-301260
K051595TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.2006-07-264050

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