QAQ
5 FDA 510(k) clearances · Product code
265 daysmedian time to decision
536 days90th percentile
5clearances measured
FDA profile
- Official device name
- Adjunctive Predictive Cardiovascular Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2210
- Medical specialty
- Cardiovascular
- FDA definition
- The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
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| 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 – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure (K183646) | Edwards Lifeciences, LLC | 2019-05-21 |
| Acumen Hypotension Prediction Index (HPI) Feature Software (DEN160044) | Edwards Lifesciences, LLC | 2018-03-16 |
Track QAQ automatically
Every clearance here is in the API, with alerts when new ones post.