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

DQE — Predicate Candidate Screening

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

71 daysmedian FDA review time

194 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K172423	PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter,	Edwards Lifescience, LLC	2018-02-20	194	1
K160645	PreSep Oligon Oximetry Catheter	Edwards Lifesciences, LLC	2016-06-16	101	0
K140129	PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VE	Icu Medical, Inc.	2014-07-02	167	0
K110167	PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM,	Edwards Lifesciences, LLC	2011-02-18	29	0
K091268	HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETE	Hospira, Inc.	2009-09-18	141	0
K062999	OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARI	Hospira, Inc.	2006-11-03	32	0
K061585	OPTICATH CENTRAL VENOUS OXIMETRY CATHETER	Hospira, Inc.	2006-10-05	120	0
K061450	HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-	Hospira, Inc.	2006-08-04	71	0
K061159	OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WIT	Hospira, Inc.	2006-06-26	61	0
K060093	PRESEP OLIGON OXIMETRY CATHETERS	Edwards Lifesciences, LLC	2006-04-28	106	0
K053609	PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL	Edwards Lifesciences, LLC	2006-02-28	63	0
K926450	EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH	Baxter Healthcare Corp	1993-02-22	60	0
K915073	MARQUETTE SV O2 MODULE	Marquette Electronics, Inc.	1992-12-29	417	0
K905458	SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER	Baxter Healthcare Corp	1991-02-07	64	0
K901736	OXIMETRY PROBE CATHETERS	Baxter Healthcare Corp	1990-09-11	147	0
K864745	POET OXIMETER	Criticare Systems, Inc.	1987-06-02	179	0
K820674	OPTICATH	Oximetrix, Inc.	1982-03-25	14	0
K781134	CATHETER, THERMAL DILUTION FIBEROPTIC	Oximetrix, Inc.	1978-08-17	42	0
K760234	OXIMETER, IN VIVO CATHETER	Oximetrix, Inc.	1976-08-23	39	0

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