Atlas FDA

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

Edwards Lifesciences — Predicate Candidate Screening

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

109 daysmedian FDA review time
226 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECEdwards Lifesciences2026-06-261790
K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences2026-06-051430
K254279Edwards eSheath+ introducer setEdwards Lifesciences2026-04-171080
K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTAEdwards Lifesciences2025-12-181280
K253034HemoSphere Stream ModuleEdwards Lifesciences2025-10-21290
K252364Edwards eSheath Optima introducer setEdwards Lifesciences2025-08-29310
K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology MoEdwards Lifesciences2025-07-232260
K244046Edwards eSheath Optima introducer setEdwards Lifesciences2025-03-27870
K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCREdwards Lifesciences2024-12-091150
K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences2024-10-162260
K241330Fogarty Fortis Arterial Embolectomy CatheterEdwards Lifesciences2024-07-02530
K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar PaciEdwards Lifesciences2024-06-271921
K233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards Lifesciences2024-05-221730
K233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathEdwards Lifesciences2024-05-201890
K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A,Edwards Lifesciences2024-02-05560
DEN190029Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences2020-11-135290
K200258Edwards eSheath Introducer SetEdwards Lifesciences2020-03-09350
K153069Edwards Balloon CatheterEdwards Lifesciences2016-01-07770
K152225Edwards eSheath Introducer SetEdwards Lifesciences2015-11-241090
K142199Ascendra Balloon Aortic Valvaloplasty CatheterEdwards Lifesciences2014-10-29790
K141696EDWARDS ESHEATH INTRODUCER SETEdwards Lifesciences2014-09-18860
K110597EV1000 CLINICAL PLATFORMEdwards Lifesciences2011-06-141040

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