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

Acumen Medical, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time

118 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K083855	MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPI	Acumen Medical, Inc.	2009-02-17	55
K080500	MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS	Acumen Medical, Inc.	2008-03-13	17
K070396	MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS	Acumen Medical, Inc.	2007-05-22	99
K070051	ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM	Acumen Medical, Inc.	2007-04-06	92
K070197	ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-ST	Acumen Medical, Inc.	2007-02-23	32
K062145	MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-	Acumen Medical, Inc.	2006-08-23	27
K062084	7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-	Acumen Medical, Inc.	2006-08-18	28
K053400	ACUMEN SINGLE-LUMEN DELIVERY SHEATH	Acumen Medical, Inc.	2006-06-19	195
K051515	MODIFIED ACUMEN SHEATH, MODEL TTW 10-65	Acumen Medical, Inc.	2005-09-01	85
K050015	MODIFIED ACUMEN SHEATH, MODEL TTWO767	Acumen Medical, Inc.	2005-02-03	30
K042381	CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508	Acumen Medical, Inc.	2004-12-28	118
K042376	ACUMEN SHEATH, MODEL TTW7807	Acumen Medical, Inc.	2004-10-26	55

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