Atlas FDA

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

Edwards Lifesciences, LLC — Predicate Candidate Screening

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

109 daysmedian FDA review time
265 days90th percentile
136clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251326Respiration Rate algorithmEdwards Lifesciences, LLC2026-06-114080
K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC2026-02-241510
K251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLC2025-09-23880
K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLC2025-09-171070
K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC2025-05-152650
K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VoluEdwards Lifesciences, LLC2025-03-211780
K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC2024-08-282300
K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC2024-08-022280
K233824Swan-Ganz catheterEdwards Lifesciences, LLC2024-06-061881
K233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLC2024-05-221730
K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC2023-11-172560
K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere AltEdwards Lifesciences, LLC2023-10-31910
K230919Acumen IQ finger cuffEdwards Lifesciences, LLC2023-10-242040
K230579Smart Wedge algorithmEdwards Lifesciences, LLC2023-08-181690
K231038Global Hypoperfusion Index (GHI) AlgorithmEdwards Lifesciences, LLC2023-07-261050
K231035FusedCO AlgorithmEdwards Lifesciences, LLC2023-07-12920
K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, AEdwards Lifesciences, LLC2023-06-091680
K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC2023-06-081500
K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC2023-05-261710
K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2022-12-221500
K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVPEdwards Lifesciences, LLC2022-11-221620
K221833HemoSphere Advanced Monitor, HemoSphere ClearSight ModuleEdwards Lifesciences, LLC2022-11-071370
K221528Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon AtEdwards Lifesciences, LLC2022-08-22880
K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HeEdwards Lifesciences, LLC2022-06-222120
K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC2022-02-142650
K203224Acumen Hypotension Prediction Index, HemoSphere Advanced MonEdwards Lifesciences, LLC2021-07-302700
K203687HemoSphere Advanced Monitor, HemoSphere ClearSight Module, AEdwards Lifesciences, LLC2021-05-281620
K203490FORE-SIGHT ELITE Absolute Tissue OximeterEdwards Lifesciences, LLC2021-02-10750
K203131EV1000 Clinical Platform Non-Invasive (NI) or ClearSight SysEdwards Lifesciences, LLC2021-01-22950
K193379Fogarty Arterial Embolectomy Catheter, Fogarty Biliary BalloEdwards Lifesciences, LLC2020-06-121902
K200499QuickDraw Venous CannulaEdwards Lifesciences, LLC2020-03-29300
K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral VeEdwards Lifesciences, LLC2020-03-13290
K193466Swan-Ganz CathetersEdwards Lifesciences, LLC2020-02-16620
K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC2019-12-17290
K192762Physio Flex Annuloplasty RingEdwards Lifesciences, LLC2019-12-16770
K192058EV1000 Clinical Platform NI, EV1000 Clinical PlatformEdwards Lifesciences, LLC2019-08-30290
K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuEdwards Lifesciences, LLC2019-08-292060
K190130The ClearSight finger cuffsEdwards Lifesciences, LLC2019-06-211440
K191089Edwards Pressure CableEdwards Lifesciences, LLC2019-06-13500
K182245EV1000 Clinical Platform Non-Invasive (NI) with ClearSight FEdwards Lifesciences, LLC2018-11-301020
K180881HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC2018-11-162260
K181684VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC2018-11-081351
K180275VAMP Optima closed blood sampling systemEdwards Lifesciences, LLC2018-10-242660
K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC2018-04-051360
DEN160044Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences, LLC2018-03-165360
K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC2017-11-17730
K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2017-10-231121
K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HeEdwards Lifesciences, LLC2017-04-141342
K163693IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC2017-01-26291
K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC2016-11-281330

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