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

Argon Medical Corp. · Predicate Candidate Screening

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

69 daysmedian FDA review time

169 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K904994	CLOSED SYSTEM FLUSH SET	Argon Medical Corp.	1991-01-15	69	0
K895511	CATHETER BALLOON DILATOR PRESSURE GAUGE	Argon Medical Corp.	1990-02-28	169	0
K894157	OBTURATOR	Argon Medical Corp.	1989-09-28	106	0
K891022	INTRODUCER FOR PTCA GUIDING CATHETERS	Argon Medical Corp.	1989-05-19	80	0
K884375	TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER	Argon Medical Corp.	1989-01-11	85	0
K882221	OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE	Argon Medical Corp.	1988-08-12	78	0
K871297	KADIR HI-TORQUE GUIDE WIRE	Argon Medical Corp.	1987-04-10	10	0
K853312	ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES	Argon Medical Corp.	1985-09-12	36	0
K852880	PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET)	Argon Medical Corp.	1985-08-29	51	0
K844555	PATHFINDER CARDIOVASCULAR CATHETER	Argon Medical Corp.	1985-03-27	126	0
K842039	ARGON DUAL LUMEN HEMODIALYSIS, CATHETER	Argon Medical Corp.	1985-01-29	253	0
K841926	HYDROGLIDE SPRING GUIDE WIRES	Argon Medical Corp.	1985-01-02	237	0
K833303	DUOFLO 6F	Argon Medical Corp.	1983-12-27	95	0
K832030	HEPARIN COATED STAINLESS STEEL/TEFLON	Argon Medical Corp.	1983-09-29	98	0
K831453	SILCATH CENTRAL CATHETER TRAY W/18 GA	Argon Medical Corp.	1983-07-28	84	0
K831451	SILCATH CENTRAL CATHETER TRAY SIZE-	Argon Medical Corp.	1983-06-08	34	0
K831171	DIGICATH	Argon Medical Corp.	1983-05-25	44	0
K820883	SEPTISLEEVE	Argon Medical Corp.	1982-04-29	30	0
K790353	ACUTE RENAL DIALYSIS TRAY	Argon Medical Corp.	1979-04-20	57	0
K781333	CENTRAL CATHETER TRAY	Argon Medical Corp.	1978-10-24	83	2
K780871	ARTERIAL LINE KIT	Argon Medical Corp.	1978-06-14	15	8
K780673	CENTRAL CATHETER KIT	Argon Medical Corp.	1978-05-16	22	0
K780259	CATHETERIZATION TRAY & KIT	Argon Medical Corp.	1978-04-18	62	0
K780126	DILATOR, VESSEL & INTRODUCER, SHEATH	Argon Medical Corp.	1978-03-02	37	3
K772369	NEEDLES USED IN ANGIOGRAPHIC PROCED.	Argon Medical Corp.	1978-01-24	28	0
K770290	MONITORING KIT, CENTRAL VENOUS PRESSURE	Argon Medical Corp.	1977-03-15	29	0
K760498	TRAY, DISPOSABLE	Argon Medical Corp.	1976-11-02	71	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