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

Vertex Medical Corp. — Predicate Candidate Screening

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

46 daysmedian FDA review time

65 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K833742	ESCHMANN DILATION CATHETER	Vertex Medical Corp.	1984-04-24	181
K834476	NEPHROSTOMY/BILIARY DRAINAGE BAG	Vertex Medical Corp.	1984-02-04	46
K832380	PROTECTIVE SLEEVE	Vertex Medical Corp.	1983-11-28	132
K831666	SIALOGRAPHY NEEDLE	Vertex Medical Corp.	1983-07-12	50
K830576	LYMPHANGIOGRAPHY SET	Vertex Medical Corp.	1983-03-17	22
K830420	POLYETHYLENE MONITORING CONNECTORS	Vertex Medical Corp.	1983-02-28	20
K830237	TRANSLUCENT POLY. CATH. CONNECTOR AND	Vertex Medical Corp.	1983-02-18	24
K823253	VERTEX MONITORING CATHETER	Vertex Medical Corp.	1982-12-30	59
K823190	BACKSTOP VALVE W/SIDE ARM	Vertex Medical Corp.	1982-12-30	65
K823340	CLEAR VINYL MONITORING CONNECTOR	Vertex Medical Corp.	1982-12-30	52
K823192	TUOHY-BORST ADAPTER W/SIDE ARM	Vertex Medical Corp.	1982-12-30	65
K823254	REUSABLE METAL STOPCOCK	Vertex Medical Corp.	1982-12-30	59
K823256	ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE	Vertex Medical Corp.	1982-12-30	59
K823191	DISPOSABLE PLASTIC STOPCOCK	Vertex Medical Corp.	1982-12-30	65
K823255	NON-STERILE REUSABLE NEEDLES	Vertex Medical Corp.	1982-11-22	21
K822593	PERCUTANEOUS CATHETER INTRODUCER SET	Vertex Medical Corp.	1982-09-28	32
K822598	TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS	Vertex Medical Corp.	1982-09-28	32
K822594	POLYETHYLENE CARDIOVASCULAR CATHETER	Vertex Medical Corp.	1982-09-28	32
K822595	VESSEL DILATOR	Vertex Medical Corp.	1982-09-28	32
K822596	VERTEX PERCUTANEOUS PUNCTURE NEEDLE	Vertex Medical Corp.	1982-09-21	25
K822597	GUIDE WIRE	Vertex Medical Corp.	1982-09-21	25

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