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

CCE — Predicate Candidate Screening

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

91 daysmedian FDA review time

318 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K935778	VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM	Via Medical Corp.	1996-12-05	1098
K912145	SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA	S & W Medico Teknik	1992-05-05	392
K910453	TOPS NEEDLE TIP PROBE & PVC TIP PROBE	Baxter Healthcare Corp	1991-08-13	193
K905397	PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM	Puritan Bennett Corp.	1991-05-14	165
K896311	OPTEX BLOOD GAS MONITORING SYSTEM	Optex Biomedical	1990-01-03	63
K890624	TISSUE OXYGEN MONITOR SYSTEM, MODEL II	Baxter Healthcare Corp	1989-12-22	318
K895149	NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY	Shiley, Inc.	1989-11-28	97
K895150	CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING	Shiley, Inc.	1989-11-28	97
K884063	BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM	C.R. Bard, Inc.	1988-12-16	81
K875225	UMBILICAL ARTERY OXYGEN SENSOR	Ohmeda Medical	1988-03-04	73
K872896	UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100	American Bentley	1988-02-12	204
K872125	BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM	C.R. Bard, Inc.	1987-12-11	192
K860808	CONTINUCATH	Orange Medical Instruments, Inc.	1986-03-13	9
K860106	OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100	American Bentley	1986-02-26	44
K853786	OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100	American Bentley	1985-10-16	36
K843912	INTRAVASCULAR BLOOD GAS SYSTEM	Cardiovascular Devices, Inc.	1985-01-10	99
K840102	ARTERIAL BLOOD GAS INTERPRETATION PROG	M. D. Software, Inc.	1984-02-04	25
K832793	NEOCATH 1000 W/HEPCOTE	Orange Medical Instruments, Inc.	1983-09-26	38
K811071	VENOUS OXYGEN PROBE	G.D. Searle and Co.	1981-05-05	15
K781271	MONITOR, PO2, INTRAVASCULAR	Roche Medical Electronics, Inc.	1978-10-12	80
K780850	SEARLE NEONATAL OXYGEN PROBE	Will Ross Co.	1978-08-23	93
K771116	CATHETER, PO2, INTRAVASUCLAR, CITADEL	Sherwood Medical Industries	1977-09-15	91
K760350	MONITOR, CITADEL INTRAVASCULAR PO2	Sherwood Medical Industries	1976-10-29	88

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