510(k) K242518
- Device
- Hypertension Prediction Index (HePI) Algorithm
- Applicant
- Edwards Lifesciences, LLC
- 510(k) number
- K242518
- Product code
- QAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-15
- Date received
- 2024-08-23
- Regulation
- 870.2210
- Classification name
- Adjunctive Predictive Cardiovascular Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Daphney Germain-Kolawole
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 3006082230
- 2648045
- 1018233
- 3013596024
- 3013500228
- 3018940143
- 9615817
- 2015691
- 3004832480
- 3037724692
- 3032916632
- 2133641
- 3030125003
Source Documents#
Other 510(k) Records For Product Code QAQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023-06-08 |
| K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021-07-30 |
| 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 | Edwards Lifeciences, LLC | 2019-05-21 |
| DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences, LLC | 2018-03-16 |