Atlas FDA

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

Thornhill Research, Inc. · Predicate Candidate Screening

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

336 daysmedian FDA review time
573 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
DEN170044ClearMateThornhill Research, Inc.2019-03-145730
K161420MOVES SLCThornhill Research, Inc.2017-06-063790
K140264MADMThornhill Research, Inc.2015-01-053360
K140049MOVES SLCThornhill Research, Inc.2014-05-291400
K093261MOVESThornhill Research, Inc.2010-03-261582

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