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

Therex Corp. — Predicate Candidate Screening

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

94 daysmedian FDA review time

231 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K953110	LOW PROFILE TITANIUM MODEL CATALOG #1003	Therex Corp.	1995-09-13	72	0
K953017	LOW PROFILE TITANIUM MODEL CATALOG #1003	Therex Corp.	1995-09-08	71	0
K952537	THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.	Therex Corp.	1995-07-06	36	0
K950212	A2 DETACHED DUAL PORT SYSTEM	Therex Corp.	1995-04-13	84	1
K950131	1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL	Therex Corp.	1995-03-23	69	0
K942412	THEREX LOW-PROFILE PORT - TITANIUM MODEL	Therex Corp.	1994-08-19	91	1
K934802	THEREX LOW-PROFILE PORT-TITANIUM	Therex Corp.	1994-03-22	166	5
K934792	THEREX LOW-PROFILE PORT	Therex Corp.	1994-03-22	167	1
K936012	THEREX LOW PROFILE PORT-TITANIUM MODEL	Therex Corp.	1994-03-22	96	0
K933350	THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CAT	Therex Corp.	1994-02-23	229	1
K933316	THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM	Therex Corp.	1994-02-23	231	5
K932447	THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D.	Therex Corp.	1994-02-09	265	1
K932671	THEREX R-PORT	Therex Corp.	1994-02-07	250	0
K936029	NON-CORNING (HUBER) NEEDLE	Therex Corp.	1994-02-04	49	0
K925373	THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D	Therex Corp.	1993-05-06	195	1
K926011	A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI	Therex Corp.	1993-03-19	123	2
K922434	A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT	Therex Corp.	1992-11-06	168	1
K921379	A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT	Therex Corp.	1992-11-06	228	1
K921475	A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM	Therex Corp.	1992-10-16	200	8
K911055	A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT	Therex Corp.	1991-04-19	42	1
K903691	A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.	Therex Corp.	1990-10-12	58	1
K902166	WINGED INFUSION SET	Therex Corp.	1990-08-17	94	0
K896093	A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT	Therex Corp.	1989-12-06	48	0
K893460	A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM	Therex Corp.	1989-06-23	51	0
K882230	A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED	Therex Corp.	1988-07-29	63	2
K875214	A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM	Therex Corp.	1988-02-19	63	2

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