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

Oximetrix, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time

110 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K853018	MODEL 3000 OPTICATH COMPUTER	Oximetrix, Inc.	1986-01-13	180	2
K842622	HEMO STATIC/ESU SCALPEL SYSTEM	Oximetrix, Inc.	1984-10-23	110	0
K833966	PUMP INFUSION WEARABLE INFUSION PUMP	Oximetrix, Inc.	1984-01-25	70	0
K823007	OPTICATH HEPARIN COATED, FLOW-DIRECT	Oximetrix, Inc.	1982-11-01	20	0
K821057	FLOW DIRECTED THERMAL-DILUTION INFUSION	Oximetrix, Inc.	1982-05-18	32	0
K821056	FLOW DIRECTED THERMAL-DILUTION CATHETER	Oximetrix, Inc.	1982-05-18	33	0
K820674	OPTICATH	Oximetrix, Inc.	1982-03-25	14	0
K811391	OXIMETRIX ACCU SAT CPB	Oximetrix, Inc.	1981-07-20	63	0
K791868	OXIMETRIX SHAW HEMOSTATIC SURG. SYS.	Oximetrix, Inc.	1980-01-04	106	0
K781879	HEATER, OXIMETER SYSTEM	Oximetrix, Inc.	1979-01-08	63	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