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

Endocardial Solutions, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time
203 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K042493ENSITE SYSTEM, MODEL EE3000Endocardial Solutions, Inc.2004-10-15310
K033211ENSITE SYSTEMEndocardial Solutions, Inc.2003-10-30270
K030129MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000Endocardial Solutions, Inc.2003-04-22980
K012926MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000Endocardial Solutions, Inc.2001-09-28280
K001437ENSITE 3000 SYSTEM, MODEL EE3000Endocardial Solutions, Inc.2000-06-07300
K993376ENSTYLET MODELS EC0010, EC0020Endocardial Solutions, Inc.2000-01-05900
K992479ENSITE 3000 SYSTEMEndocardial Solutions, Inc.1999-12-021290
K983456ENSITE 3000 SYSTEMEndocardial Solutions, Inc.1999-04-212030

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