Atlas FDA

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

Mesure Technology · Predicate Candidate Screening

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

77 daysmedian FDA review time
170 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013779THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST853Mesure Technology2002-03-291360
K011254EAR THERMOMETER, MODELS ST613C AND ST613FMesure Technology2001-07-10770
K011585FAST THERMOMETER MODELS ST713C AND ST713FMesure Technology2001-06-13210
K981337DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834AMesure Technology1998-09-301700
K962520DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND STMesure Technology1996-09-12770

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