Atlas FDA

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

Quantitative Medicine, Inc. — Predicate Candidate Screening

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

162 daysmedian FDA review time
366 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K963608QUANTITATIVE SENTINEL SYSTEMQuantitative Medicine, Inc.1997-03-111820
K960109QUANTITATIVE SENTINEL SYSTEMQuantitative Medicine, Inc.1996-08-012030
K923255Q-SDQuantitative Medicine, Inc.1992-10-05950
K912462Q-MS NEUROMUSCULAR STIMULATORQuantitative Medicine, Inc.1992-06-043660
K912460Q-TENSQuantitative Medicine, Inc.1991-11-131620
K912463MICRO-QQuantitative Medicine, Inc.1991-11-131620
K904603QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEMQuantitative Medicine, Inc.1991-01-251070
K833395SENTINEL SYSTEMSQuantitative Medicine, Inc.1984-01-101020

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