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

Cardiovascular Diagnostics, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
307 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013305ENOXAPARIN TEST CARDCardiovascular Diagnostics, Inc.2002-08-233230
K994194(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINTCardiovascular Diagnostics, Inc.2000-03-281060
K994159HMP CONTROLS (TAS) RAPIDPOINTCardiovascular Diagnostics, Inc.2000-02-15680
K993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRACardiovascular Diagnostics, Inc.2000-01-14880
K990566TAS ANALYZER, MODEL 1009Cardiovascular Diagnostics, Inc.1999-05-14810
K981206TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)Cardiovascular Diagnostics, Inc.1998-05-26550
K981178THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT Cardiovascular Diagnostics, Inc.1998-04-27260
K971748TAS PT-NCTEST CONTROLSCardiovascular Diagnostics, Inc.1997-05-29170
K961814THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLCardiovascular Diagnostics, Inc.1996-08-13950
K961189TAS A PTT TEST CONTROLSCardiovascular Diagnostics, Inc.1996-06-05710
K960234TAS HMT CONTROLSCardiovascular Diagnostics, Inc.1996-05-301340
K954625PROTHROMBIN TIME TEST CARDCardiovascular Diagnostics, Inc.1996-03-111660
K943283HEPARIN MANAGEMENT TEST CARD; HMT CARDCardiovascular Diagnostics, Inc.1995-05-103070

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