Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

DTY · Predicate Candidate Screening

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

143 daysmedian FDA review time

185 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093650	BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM	Medtronic, Inc.	2010-02-17	84	0
K963698	CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4	International Biophysics Corp.	1997-03-20	185	0
K954501	BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM	Medtronic Bio-Medicus, Inc.	1996-01-16	110	0
K902654	CDI (TM) SYSTEM 100 MONITORING SYSTEM	3M Health Care, Ltd.	1990-11-05	143	5
K900860	PERFUSION MONITOR	Cardio Metrics, Inc.	1990-08-14	172	0
K864703	MODIFIED GAS-STAT(TM) MONITORING SYSTEM	Cardiovascular Devices, Inc.	1987-02-19	79	0
K840749	GAST STAT MONITORING SYSTEM	Cardiovascular Devices, Inc.	1984-04-17	54	0
K822000	EXTRACORPOREAL BLOOD GAS SYSTEM	Cardiovascular Devices, Inc.	1982-12-22	168	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