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

Oscor, Inc. — Predicate Candidate Screening

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

94 daysmedian FDA review time

183 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K210627	Breezeway II	Oscor, Inc.	2021-06-03	93	0
K151951	Destino Reach	Oscor, Inc.	2015-09-22	69	0
K143463	IS4/DF4 Port Plug	Oscor, Inc.	2015-03-19	105	0
K140917	INTRODUCER, MODEL ADELANTE MAGNUM	Oscor, Inc.	2014-07-09	90	0
K140406	DESTINO TWIST, STEERABLE GUIDING SHEATH	Oscor, Inc.	2014-04-17	58	0
K130633	INTRODUCER SETS, MODEL ADELANTE RADIAL	Oscor, Inc.	2014-02-13	339	0
K130843	SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE	Oscor, Inc.	2014-01-08	287	0
K130104	GUIDEWIRE, PURSUER SERIES	Oscor, Inc.	2013-06-13	149	0
K122958	DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY	Oscor, Inc.	2012-12-13	79	0
K122960	STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO	Oscor, Inc.	2012-12-13	79	0
K122084	INTRODUCER SET, MODEL ADELANTE-S SERIES	Oscor, Inc.	2012-08-29	44	3
K120459	STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO	Oscor, Inc.	2012-06-29	135	0
K101497	DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY	Oscor, Inc.	2010-10-20	141	0
K092118	ANGIOGRAPHIC CATHETER, MODEL ANGIOS	Oscor, Inc.	2010-01-13	183	0
K090114	MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE	Oscor, Inc.	2009-06-04	134	0
K081986	SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE	Oscor, Inc.	2008-11-14	123	0
K081052	OCCLUSION BALLOON CATHETER, MODEL VENOS	Oscor, Inc.	2008-06-18	65	0
K072770	TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)	Oscor, Inc.	2008-01-22	116	0
K073100	INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S	Oscor, Inc.	2007-11-30	28	2
K070926	ELECTRODE/EXTENSION CABLES, MODELS ATAR	Oscor, Inc.	2007-06-07	65	2
K041809	PERMANENT PACING LEAD, MODEL PY2	Oscor, Inc.	2004-08-06	31	1
K040569	PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJ	Oscor, Inc.	2004-04-07	34	1
K031164	PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV	Oscor, Inc.	2003-06-19	66	0
K024053	PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB	Oscor, Inc.	2003-01-31	53	0
K024156	PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPO	Oscor, Inc.	2003-01-14	28	0
K020669	PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETIT	Oscor, Inc.	2002-03-28	27	0
K013339	PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS	Oscor, Inc.	2001-11-08	30	0
K010787	PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS	Oscor, Inc.	2001-05-22	68	1
K003918	OSCOR PERMANENT PACING LEAD RZ MODEL SERIES	Oscor, Inc.	2001-05-22	154	0
K831926	IMPLANTABLE ENDOCARDIAL PACING LEADS	Oscor, Inc.	1984-03-12	271	0
K831768	EXTERNAL PULSE GENERATOR FOR TEMP. STIM	Oscor, Inc.	1983-12-16	198	0
K831804	MULTIPOLAR TEMPORARY CARDIAC	Oscor, Inc.	1983-10-20	139	0
K831751	LEAD INTRODUCER SETS-EB-S8 & EB-S12	Oscor, Inc.	1983-10-20	141	1
K831695	TEMP. CARDIAC PACING WIRE TME 60/61/65	Oscor, Inc.	1983-10-20	148	1
K831997	IMPLANTABLE ENDOCARDIAL PACING LEADS	Oscor, Inc.	1983-10-20	121	0
K831767	IMPLANTABLE CARDIAC PACING LEADS	Oscor, Inc.	1983-07-26	55	0
K823898	MODEL MF..D & MX..D PACEMAKER LEADS	Oscor, Inc.	1983-04-30	124	0
K823889	MODEL JY PACEMAKER LEAD - VARIOUS	Oscor, Inc.	1983-04-30	124	0
K823893	MODEL MZ PACEMAKER LEAD-VARIOUS	Oscor, Inc.	1983-04-30	124	0
K823897	MODEL SF. D&SX.D PACEMAKER LEADS	Oscor, Inc.	1983-04-30	124	0
K823895	MODEL RF. D&RX..D PACEMAKER LEADS	Oscor, Inc.	1983-04-30	124	0
K830950	VASCULAR PRODUCTS IMPLANTABLE PACING	Oscor, Inc.	1983-04-18	24	0
K830772	TEMP. PACING LEAD, BIPOLAR #TH60, 90/110	Oscor, Inc.	1983-04-18	38	0
K823891	MODEL KY PACEMAKER LEAD - VARIOUS	Oscor, Inc.	1983-03-31	94	0
K823890	MODEL ZY PACEMAKER LEAD-VARIOUS	Oscor, Inc.	1983-03-31	94	0
K823448	IMPLANTABLE PACING LEAD TINED #3390 &	Oscor, Inc.	1982-12-03	17	0
K823446	PRODUCTS IMPLANTABLE PACING LEAD,TINED	Oscor, Inc.	1982-12-03	17	0
K791732	IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC	Oscor, Inc.	1979-09-19	14	0
K782018	LEADS, IMPLANTABLE CARDIAC PACEMAKERS	Oscor, Inc.	1979-06-04	181	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