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

Hdc Corp. — Predicate Candidate Screening

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

85 daysmedian FDA review time

343 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days
K071875	V-CATH POLY PICC	Hdc Corp.	2007-11-05	122
K023342	NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, N	Hdc Corp.	2004-03-02	512
K033853	MODIFICATION TO V-CATH POLY PICC	Hdc Corp.	2004-01-14	34
K032404	SELDINGER SAFETY NEEDLE INTRODUCER	Hdc Corp.	2003-09-10	37
K022752	PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-	Hdc Corp.	2003-09-09	386
K022099	SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-	Hdc Corp.	2002-09-20	85
K010425	EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)	Hdc Corp.	2001-03-15	30
K994059	CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10,	Hdc Corp.	2000-10-13	319
K002770	IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 70	Hdc Corp.	2000-09-26	20
K983119	ENTERO-TEST HP, MODEL #102-01	Hdc Corp.	1999-03-15	188
K983916	V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)	Hdc Corp.	1998-11-23	20
K983409	V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APP	Hdc Corp.	1998-10-16	18
K964966	V-CATH	Hdc Corp.	1997-03-05	84
K953300	V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETE	Hdc Corp.	1996-04-30	291
K951384	V-CATH PERCUTANEOUS INTRODUCER KIT	Hdc Corp.	1995-06-23	88
K951098	HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER	Hdc Corp.	1995-06-02	85
K945473	V-CATH BREAKAWAY NEEDLE INTRODUCER	Hdc Corp.	1995-01-20	73
K913386	CHEMO-PORT	Hdc Corp.	1992-01-10	165
K890116	ENTERAL FEEDING TUBE	Hdc Corp.	1989-04-05	84
K881504	VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT	Hdc Corp.	1988-06-22	72
K875171	J-CATH(TM)	Hdc Corp.	1988-04-06	111
K874184	CHEMO-PORT	Hdc Corp.	1987-12-30	77
K873165	CHEMO-PORT NON-CORING NEEDLES	Hdc Corp.	1987-12-03	114
K863819	CHEMO-CATH INTRAPERITONEAL CATHETER	Hdc Corp.	1987-02-04	127
K853332	HDC CHEMO-PORT (VASCULAR)	Hdc Corp.	1986-07-17	343
K862358	EPICATH	Hdc Corp.	1986-07-07	14
K851078	HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER	Hdc Corp.	1985-04-19	32
K841289	RECTAL IRRIGATION TUBE	Hdc Corp.	1984-07-06	100
K834091	SILCATH	Hdc Corp.	1984-03-06	99
K831715	NEUROTRAC	Hdc Corp.	1983-07-07	41

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