Adjunctive Predictive Cardiovascular Indicator
FDA product code QAQ · Class II (moderate risk) · 21 CFR 870.2210 · Cardiovascular
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.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242518 | Hypertension Prediction Index (HePI) AlgorithmQAQ · Traditional | Edwards Lifesciences, LLC | 05/15/2025SE |
| K230057 | Acumen Hypotension Prediction Index (HPI) AlgorithmQAQ · Traditional | Edwards Lifesciences, LLC | 06/08/2023SE |
| K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformQAQ · Traditional | Edwards Lifesciences, LLC | 07/30/2021SE |
| K183646 | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension…QAQ · Traditional | Edwards Lifeciences, LLC | 05/21/2019SE |