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

Clincal Instruments Corp. — Predicate Candidate Screening

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

153 daysmedian FDA review time

277 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K902327	EMBOLECTOMY CATHETER	Clincal Instruments Corp.	1991-02-25	277	3
K860742	CAROTID BYPASS SHUNT	Clincal Instruments Corp.	1986-05-28	90	0
K860743	CAROTID BYPASS SHUNT WITH SAMPLING ARM	Clincal Instruments Corp.	1986-05-28	90	0
K852704	TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT	Clincal Instruments Corp.	1985-11-26	153	0
K844918	OCCLUSION & OCCLUSION-IRRIGATION	Clincal Instruments Corp.	1985-08-05	229	0
K821220	MULTILUMEN INTRAVENOUS INFUSION CATHETER	Clincal Instruments Corp.	1982-07-09	73	0
K790034	INTRODUCERS	Clincal Instruments Corp.	1979-02-01	29	0
K771043	SWAN GANZ	Clincal Instruments Corp.	1977-12-20	194	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