# K203224: Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jul 30, 2021 after 270 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: 27 generations back to K941811 (1994). 242 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 244 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module, Edwards Lifesiences, LLC (2020) Summary page 4.

## Most influential descendants
- K230842: SignalHF (IM008) (2023), 0 descendants of its own

## Indications for use
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) 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 no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

Source page: https://510kreport.com/device/K203224
Methodology: https://510kreport.com/methodology