# Edwards Lifesciences, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 177 (1979–2026): 156 510(k) clearances, 2 De Novo grants and 19 original PMA approvals
- Names in FDA's records: Edwards Lifesciences, LLC (155); Edwards Lifesciences (22)
- Product codes: DWF (19), DQK (15), DYB (14), DXG (11), DXN (9), KRH (9), FGE (7), DXE (6), DYE (5), DYG (5), DXC (5), DXO (5)
- 510(k) review time since 2016: median 134 days, against 136 for FDA's reviews in the same codes and years (20 of 49 faster)
- Predicates its devices cite: 247 (116 its own); citations of its devices by later devices: 177 (116 its own)
- Recalls linked to its devices: 180 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baxter Healthcare Corp: 24 (https://510kreport.com/company/baxter-healthcare)
- American Edwards Laboratories: 9 (https://510kreport.com/company/american-edwards-laboratories)
- Orbus Medical Technologies: 6 (https://510kreport.com/company/orbus-medical-technologies)
- Edwards Lifesiences, LLC: 6 (https://510kreport.com/company/edwards-lifesiences)
- Research Medical, Inc.: 6 (https://510kreport.com/company/research-medical)
- Cordis Corp.: 5 (https://510kreport.com/company/cordis)
- Baxter Edwards: 5 (https://510kreport.com/company/baxter-edwards)
- Edwards Lifeciences, LLC: 4 (https://510kreport.com/company/edwards-lifeciences)

## Firms that cite its devices most
- Edwards Lifesiences, LLC: 5 (https://510kreport.com/company/edwards-lifesiences)
- Edwards Lifesciencess, LLC: 4 (https://510kreport.com/company/edwards-lifesciencess)
- Edwards Lifeciences, LLC: 4 (https://510kreport.com/company/edwards-lifeciences)
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)
- Hospira, Inc.: 3 (https://510kreport.com/company/hospira)
- Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic)
- Cardiogard Medical, Ltd.: 2 (https://510kreport.com/company/cardiogard-medical)
- Edwards Lifescience, LLC: 2 (https://510kreport.com/company/edwards-lifescience)

## Its most-cited devices
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (2016), cited by 9
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable (2018), cited by 7
- K160084: Swan Ganz Catheters (2016), cited by 6
- DEN160044: Acumen Hypotension Prediction Index (HPI) Feature Software (2018), cited by 5
- K213682: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (2022), cited by 5
- K223865: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (2023), cited by 4

## Recent decisions
- P260007: Autus Size-Adjustable Valve (Oct 1, 2026)
- K254232: ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) (Jun 26, 2026)
- K251326: Respiration Rate algorithm (Jun 11, 2026)
- K260105: Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (Jun 5, 2026)
- K254279: Edwards eSheath+ introducer set (Apr 17, 2026)
- K253186: HemoSphere Nano Monitor (HSNANO1) (Feb 24, 2026)
- P250019: SAPIEN M3 Transcatheter Mitral Valve Replacement System (Dec 22, 2025)
- K252533: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (Dec 18, 2025)

Source page: https://510kreport.com/company/edwards-lifesciences