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

CCC — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

195 daysmedian FDA review time

669 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K071165	ISCALERT SENSOR SYSTEM	Alertis Medical AS	2007-11-07	195
K983198	TRENDCARE CALIBRATOR MODEL SCU 7007	Diametrics Medical, Ltd.	1999-11-23	438
K972314	PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7	Diametrics Medical, Ltd.	1997-12-19	182
K953893	PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM	Biomedical Sensors, Inc.	1997-11-04	810
K961790	POINT-OF-CARE BLOOD GAS MONITOR SYSTEM	Optical Sensors, Inc.	1997-04-09	335
K963935	OLYMPUS CRITICAL CARE MONITORING SYSTEM	Optical Sensors, Inc.	1997-01-23	114
K951094	POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM	Optical Sensors, Inc.	1996-01-16	313
K940188	PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYS	Biomedical Sensors, Ltd.	1995-11-13	669
K931185	SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE	Optical Sensors, Inc.	1993-10-21	226
K901548	BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS	Shiley, Inc.	1991-01-14	286
K891013	MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING	Medtronic Vascular	1989-08-02	155
K870911	INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY	American Bentley	1987-05-29	84
K780185	OXYGEN ANALYZER 110	Siemens Corp.	1978-03-17	39
K771722	SENSOMAT	Biochem International, Inc.	1977-09-26	13
K760088	ANALYZER, SENTORR BLOOD GAS	Ohio Medical Products	1976-08-06	46

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