Atlas FDA

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

Cardiovascular Devices, Inc. — Predicate Candidate Screening

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

99 daysmedian FDA review time
168 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890113THE CDI(R) SYSTEM 400Cardiovascular Devices, Inc.1989-05-231320
K884228CDI(R) 2000 BLOOD GAS MONITORCardiovascular Devices, Inc.1989-01-301150
K871221CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300Cardiovascular Devices, Inc.1987-06-05700
K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMCardiovascular Devices, Inc.1987-02-19790
K843912INTRAVASCULAR BLOOD GAS SYSTEMCardiovascular Devices, Inc.1985-01-10990
K840749GAST STAT MONITORING SYSTEMCardiovascular Devices, Inc.1984-04-17540
K831225GAS-STAT MONITORING SYSTEMCardiovascular Devices, Inc.1983-05-27420
K822000EXTRACORPOREAL BLOOD GAS SYSTEMCardiovascular Devices, Inc.1982-12-221680

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