Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Medcomp — Predicate Candidate Screening

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

105 daysmedian FDA review time

309 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K130889	SPLIT CATH RG	Medcomp	2014-04-28	395	0
K123292	T3	Medcomp	2013-06-11	232	0
K102966	2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC	Medcomp	2010-12-21	77	0
K091954	MICRO-STICK SET	Medcomp	2010-01-08	191	0
K092347	PRO-PICC CT	Medcomp	2009-09-16	43	0
K091953	PRO-PICC	Medcomp	2009-09-16	77	0
K090394	VALVED TEARWAY INTRODUCER	Medcomp	2009-09-01	196	0
K091586	VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE	Medcomp	2009-07-23	51	0
K091466	1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S	Medcomp	2009-06-17	30	0
K081775	THE MEDCOMP .010 VASCULAR GUIDEWIRES	Medcomp	2009-03-25	275	0
K081904	PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FU	Medcomp	2008-09-23	82	2
K080544	UNASSIGNED	Medcomp	2008-08-14	169	0
K072509	PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FU	Medcomp	2007-11-26	81	0
K070003	POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUM	Medcomp	2007-05-15	132	3
K061986	1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50	Medcomp	2006-08-03	21	0
K053092	MEDCOMP VASCU-SHEATH II	Medcomp	2006-08-01	271	0
K053345	PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D	Medcomp	2006-03-17	105	1
K051280	MEDCOMP SPLIT CATH II	Medcomp	2005-11-30	197	0
K040318	MEDCOMP SPLIT-CATH II	Medcomp	2005-02-03	360	0
K040328	15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER	Medcomp	2004-11-24	288	0
K033570	MEDCOMP T-3	Medcomp	2004-09-16	309	0
K040992	15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 1030	Medcomp	2004-07-29	104	0
K030502	14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55,	Medcomp	2003-05-20	90	2
K030270	3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGL	Medcomp	2003-04-11	74	0
K022678	MEDCOMP SC4	Medcomp	2003-02-24	196	0
K022570	MEDCOMP REPAIR KIT, MODEL ASPCRPK	Medcomp	2002-10-31	90	0
K022513	MEDCOMP VASCU-SHEATH INTRODUCER SET	Medcomp	2002-10-25	87	0
K020936	10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10	Medcomp	2002-10-11	203	0
K021759	14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55	Medcomp	2002-08-27	90	0
K020315	14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL	Medcomp	2002-05-24	115	0
K020465	MEDCOMP ASH SPLIT-CATH II	Medcomp	2002-05-22	99	0
K013162	14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 3	Medcomp	2001-10-19	28	0
K010306	MEDCOMP EXCELL SPLIT TIP CATHETER	Medcomp	2001-10-03	244	0
K003110	MEDCOMP BIO-CATH CATHETER LINE	Medcomp	2000-12-01	58	0
K972207	MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM	Medcomp	1998-02-23	256	0
K971281	RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE	Medcomp	1997-10-09	185	0
K953811	MEDCOMP P-CATH	Medcomp	1996-07-25	365	0
K830438	MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM	Medcomp	1983-03-17	36	0
K821955	MCSCK638 CATHETER IN A TRAY (KIT)	Medcomp	1982-07-14	14	0
K821954	MCSCK838 CATHETER IN A TRAY (KIT)	Medcomp	1982-07-14	14	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