Atlas FDA

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

Lumend, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time
234 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K043534MODIFICATION TO OUTBACK CATHETERLumend, Inc.2005-01-21301
K040771MODIFICATION TO OUTBACK CATHETERLumend, Inc.2004-04-23291
K033535LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIESLumend, Inc.2004-01-07580
K032298MODIFICATION TO OUTBACK CATHETERLumend, Inc.2003-08-26322
K031005LUMEND FRONTRUNNER GW CTO CATHETERLumend, Inc.2003-06-18790
K023114LUMEND FRONTRUNNER CTO CATHETERLumend, Inc.2003-01-231260
K023223MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETERLumend, Inc.2002-10-24270
K013284LUMEND FRONTRUNNER CTO CORONARY CATHETERLumend, Inc.2002-02-111320
K011562LUMEND PERCUTANEOUS CATHETERLumend, Inc.2002-01-162400
K014117MODIFICATION TO OUTBACK CATHETERLumend, Inc.2002-01-11281
K001577OUTBACK CATHETERLumend, Inc.2001-01-112341

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