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

DPZ — Predicate Candidate Screening

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

77 daysmedian FDA review time

147 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K042675	FLEXI-STAT SP02 EAR SENSOR	Elekon Industries U.S.A., Inc.	2004-12-06	68	0
K040831	DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 35	Datex-Ohmeda, Inc.	2004-09-02	155	5
K012333	FLEXI-SITE SP02 EAR SENSOR	Epic Medical Equipment Services, Inc.	2001-10-17	85	0
K010718	FLEXI-SITE SP02 EAR SENSOR	Epic Medical Equipment Services, Inc.	2001-03-23	11	0
K944760	DURA-Y OXYGEN TRANSDUCER, EAR CLIP	Nellcor, Inc.	1994-10-17	20	0
K942752	MARQUETTE EAR PROBE SENSOR	Marquette Electronics, Inc.	1994-09-02	84	0
K914595	PULSE RATE MONITOR	Fitness Quest, Inc.	1992-01-31	107	0
K862426	PULSE OXIMETER	Draeger Medical, Inc.	1986-09-11	77	0
K845051	VITALOG PMS-8	Vitalog Corp.	1985-05-15	147	0
K850494	OHMEDA BIOX 3700 PULSE OXIMETER	Ohmeda Medical	1985-03-28	48	0
K810363	EAR OXIMETER	Bio-Tek Instruments, Inc.	1981-02-27	16	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