# K230057: Acumen Hypotension Prediction Index (HPI) Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 8, 2023 after 150 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: 28 generations back to K941811 (1994). 243 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 249 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203687: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index, Edwards Lifesciences, LLC (2021) Summary page 5.
- DEN160044: Acumen Hypotension Prediction Index (HPI) Feature Software, Edwards Lifesciences, LLC (2018) Summary page 5.

## Most influential descendants
- K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (2024), 4 descendants of its own
- K243781: HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (2025), 2 descendants of its own
- K253186: HemoSphere Nano Monitor (HSNANO1) (2026), 0 descendants of its own
- K252533: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (2025), 0 descendants of its own
- K253034: HemoSphere Stream Module (2025), 0 descendants of its own

## Indications for use
Acumen Hypotension Prediction Index: The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient’s physiological condition for reference only and is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.

Source page: https://510kreport.com/device/K230057
Methodology: https://510kreport.com/methodology