# K242518: Hypertension Prediction Index (HePI) Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: May 15, 2025 after 265 days
- Product code: QAQ (Adjunctive Predictive Cardiovascular Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K941811 (1994). 247 ancestors in all.
No later device cites it as a predicate yet.
1 of 248 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213682: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote, Edwards Lifesciences, LLC (2022) Summary page 5.

## Indications for use
The Hypertension Prediction Index (HePI) software provides the clinician with physiological insight into an adult (18 years and older) patient’s likelihood of future hypertensive events. The HePI software is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The HePI software is considered to be additional quantitative information regarding the patient’s physiological condition for reference only and no therapeutic decisions should be made solely on the HePI parameter.

Source page: https://510kreport.com/device/K242518
Methodology: https://510kreport.com/methodology