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

Cardiovascular Diagnostic Services — Predicate Candidate Screening

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

83 daysmedian FDA review time
144 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955843TAS PTONECardiovascular Diagnostic Services1996-03-18830
K933092TAS ANALYZERCardiovascular Diagnostic Services1993-11-151440
K904325COAG-1 PT-NC TEST CARDCardiovascular Diagnostic Services1991-01-251270
K903019MODIFIED COAG-1 PT TEST CARDCardiovascular Diagnostic Services1990-08-01210
K891015COAG-1 APTT TEST CARDCardiovascular Diagnostic Services1989-05-22830
K882456COAG-I PT TEST CARDCardiovascular Diagnostic Services1988-08-25720
K882444COAG-I ANALYZER, ALPHA MODELCardiovascular Diagnostic Services1988-08-25720
K812304DORROS-SPRING PRESSURIZERCardiovascular Diagnostic Services1981-10-13560

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