Hypertension Prediction Index (HePI) Algorithm
FDA 510(k) K242518 · Edwards Lifesciences, LLC
510(k) numberK242518
Submission
- Device name
- Hypertension Prediction Index (HePI) Algorithm
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- August 23, 2024
- Decision date
- May 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAQ – Adjunctive Predictive Cardiovascular Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2210
- Specialty
- 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.
Other 510(k)s with product code QAQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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Questions and answers
When was Hypertension Prediction Index (HePI) Algorithm cleared by the FDA?
Hypertension Prediction Index (HePI) Algorithm (K242518) received a 510(k) decision of Substantially Equivalent on May 15, 2025, 265 days after the submission was received.
What is the product code of K242518?
The FDA product code is QAQ – Adjunctive Predictive Cardiovascular Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2210.