# K231038: Global Hypoperfusion Index (GHI) Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jul 26, 2023 after 105 days
- Product code: QNL (Medium-Term 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). 245 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 252 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 4.
- K200717: CLEWICU System (ClewICUServer and ClewICUnitor), Clew Medical, Ltd. (2021) Summary page 4.

## Most influential descendants
- K232294: HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One) (2023), 5 descendants of its own
- 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

## Indications for use
The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 < 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

Source page: https://510kreport.com/device/K231038
Methodology: https://510kreport.com/methodology