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

Cardio Metrics, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
294 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESCardio Metrics, Inc.1997-10-14821
K965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEMCardio Metrics, Inc.1997-08-182380
K951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRECardio Metrics, Inc.1996-10-255700
K961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLCardio Metrics, Inc.1996-07-31850
K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404Cardio Metrics, Inc.1996-02-28850
K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATIOCardio Metrics, Inc.1995-11-07350
K952562CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRECardio Metrics, Inc.1995-08-29880
K943022CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRECardio Metrics, Inc.1994-09-19870
K940984CARDIOMETRICS DUALFLOW SWITCH BOXCardio Metrics, Inc.1994-08-181700
K933320CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENTCardio Metrics, Inc.1994-08-174060
K941485CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRESCardio Metrics, Inc.1994-05-31640
K932536CARDIOMETRICS FLOWIRE & FLOMAPCardio Metrics, Inc.1993-09-281250
K925524CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)Cardio Metrics, Inc.1993-08-232940
K921563CARDIOMETRICS FLOWIRE/FLOMAP SYSTEMCardio Metrics, Inc.1992-07-01910
K912776CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUNDCardio Metrics, Inc.1992-01-091990
K905411FLOWIRE AND FLOMAPCardio Metrics, Inc.1991-03-291160
K900860PERFUSION MONITORCardio Metrics, Inc.1990-08-141720
K901733MODIFIED FLOCATH PULMONARY ARTERY CATHETERCardio Metrics, Inc.1990-07-16900
K882593MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEMCardio Metrics, Inc.1988-08-29660
K870150CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEMCardio Metrics, Inc.1987-08-072060
K863482DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICECardio Metrics, Inc.1986-10-14350
K860775MEDIASTINAL AUTOTRANSFUSION SYSTEMCardio Metrics, Inc.1986-05-28860
K860298STABLELINECardio Metrics, Inc.1986-04-02640

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