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

Cardima, Inc. — Predicate Candidate Screening

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

242 daysmedian FDA review time

553 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K060715	MODIFICATION TO: CARDIMA ABLATION SYSTEM	Cardima, Inc.	2006-05-15	59	2
K022008	CARDIMA ABLATION SYSTEM	Cardima, Inc.	2003-01-29	224	2
K974683	NAVIPORT DEFLECTABLE TIP GUIDING CATHETER	Cardima, Inc.	1999-06-22	553	0
K972803	TRACER O-T-W MAPPING DEVICE	Cardima, Inc.	1999-05-11	652	0
K982835	ELECTRODE SWITCHBOX, MODEL 11-081002	Cardima, Inc.	1998-10-29	78	0
K971975	CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER	Cardima, Inc.	1998-07-01	398	0
K973298	CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CAT	Cardima, Inc.	1998-06-26	297	0
K970853	PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)	Cardima, Inc.	1997-11-04	242	0
K955802	PATHFINDER	Cardima, Inc.	1997-01-29	404	0
K951603	CARDIMA, INC. FORERUNNER	Cardima, Inc.	1995-10-05	181	0
K932800	CARDIMA TRACKER(R) INFUSION CATHETER	Cardima, Inc.	1993-12-21	195	0
K932801	CARDIMA SEEKER AND STUBBIE GUIDEWIRES	Cardima, Inc.	1993-09-01	84	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