Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure
FDA 510(k) clearance K183646 · decided 2019-05-21
Clearance details
- K-number
- K183646
- Device name
- Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure
- Applicant
- Edwards Lifeciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-12-26
- Decision date
- 2019-05-21
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- QAQ
- Device class
- 2
- Regulation number
- 870.2210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| Acumen Hypotension Prediction Index (HPI) Algorithm (K230057) | Edwards Lifesciences, LLC | 2023-06-08 |
| Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (K203224) | Edwards Lifesciences, LLC | 2021-07-30 |
| Acumen Hypotension Prediction Index (HPI) Feature Software (DEN160044) | Edwards Lifesciences, LLC | 2018-03-16 |
Recalls involving this device
No recalls on record reference this clearance.