# Edwards Lifeciences, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 3 (2019–2022): 3 510(k) clearances
- Product codes: DQK (1), QAQ (1), DXO (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Edwards Lifesciences, LLC: 4 (https://510kreport.com/company/edwards-lifesciences)
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 4 (https://510kreport.com/company/edwards-lifesciences)
- Clew Medical, Ltd.: 1 (https://510kreport.com/company/clew-medical)

## Its most-cited devices
- K183646: Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure (2019), cited by 3
- K223127: HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (2022), cited by 1
- K183413: TruWave Disposable Pressure Transducer (2019), cited by 1

## Recent decisions
- K223127: HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (Nov 7, 2022)
- K183646: Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure (May 21, 2019)
- K183413: TruWave Disposable Pressure Transducer (May 1, 2019)

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