Atlas FDA

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

Cardiodynamics International Corp. · Predicate Candidate Screening

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

87 daysmedian FDA review time
208 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090602CARDIODYNAMICS BIOZ RX, MODEL 7101-SYSCardiodynamics International Corp.2009-05-28840
K070156BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL Cardiodynamics International Corp.2007-09-262520
K051228BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECGCardiodynamics International Corp.2005-06-10280
K041294BIOZDX HEMODYNAMIC MONITORCardiodynamics International Corp.2004-12-082080
K011439MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITORCardiodynamics International Corp.2001-11-021760
K011797BIOZTECT SENSOR AND BIOZTECT CABLECardiodynamics International Corp.2001-07-03250
K001081BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USECardiodynamics International Corp.2000-06-30870
K001100BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ Cardiodynamics International Corp.2000-05-05300
K974725BIOZ.COM SYSTEMCardiodynamics International Corp.1998-03-18900
K972320BIOZ SYSTEM & BIOZ PORTABLECardiodynamics International Corp.1997-09-11800
K963183BIOZ SYSTEMCardiodynamics International Corp.1996-11-261040

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