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

Heartport, Inc. — Predicate Candidate Screening

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

141 daysmedian FDA review time

221 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K994243	DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT	Heartport, Inc.	2000-05-05	141	0
K981995	QUICKDRAW VENOUS CANNULA	Heartport, Inc.	1999-04-20	316	1
K990772	DIRECTFLOW ARTERIAL CANNULA	Heartport, Inc.	1999-03-23	14	6
K981009	HEARTPORT ENDOPULMONARY VENT CATHETER	Heartport, Inc.	1998-09-04	170	0
K974736	HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER	Heartport, Inc.	1998-07-15	208	5
K974175	HEARTPORT ENDOAORTIC CLAMP CATHETER	Heartport, Inc.	1997-12-16	40	2
K972570	HEARTPORT INTRODUCER SHEATH	Heartport, Inc.	1997-10-01	83	5
K971291	HEARTPORT ENDOARTERIAL RETURN CANNULA	Heartport, Inc.	1997-06-17	71	6
K970496	HEARTPORT MAZE SYSTEM: CRYOPROBE SET	Heartport, Inc.	1997-05-09	88	0
K964302	HEARTPORT THORACIC TROCAR	Heartport, Inc.	1997-05-09	192	0
K964161	HEARTPORT ENDOAORTIC CLAMP	Heartport, Inc.	1997-04-04	169	4
K965051	HEARTPORT NEEDLE TROCAR	Heartport, Inc.	1997-03-12	84	0
K962835	HEARTPORT ENDOVENOUS DRAINAGE CANNULA	Heartport, Inc.	1997-02-10	203	0
K964248	HEARTPORT ENDOCORONARY SINUS CATHETR	Heartport, Inc.	1997-01-22	90	2
K961334	HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE	Heartport, Inc.	1996-11-15	221	0
K961333	HEARTPORT MULTIFIRE CLIP APPLIER	Heartport, Inc.	1996-11-15	221	0
K962366	HEARTPORT CABLE BULLDOG CLAMP	Heartport, Inc.	1996-11-07	141	0
K961463	HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, T	Heartport, Inc.	1996-10-08	174	0
K962858	HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRA	Heartport, Inc.	1996-09-30	70	0
K962510	HEARTPORT ENDOAORTIC CLAMP	Heartport, Inc.	1996-09-11	76	2
K961245	HEARTPORT ENDOPULMONARY VENT	Heartport, Inc.	1996-06-18	78	0
K961270	HEARTPORT ENDOSINUS CATHETER	Heartport, Inc.	1996-06-18	77	0
K955132	HEARTPORT ENDOAORTIC CLAMP	Heartport, Inc.	1996-06-07	211	2
K955121	HEARTPORT ENDOARTERIAL RETURN CANNUAL	Heartport, Inc.	1996-05-10	183	5

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