# K200717: CLEWICU System (ClewICUServer and ClewICUnitor)

- Pathway: 510(k) (Traditional)
- Applicant: Clew Medical, Ltd.
- Decided: Jan 9, 2021 after 297 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: 26 generations back to K941811 (1994). 239 ancestors in all.
12 later devices descend from it; 4 cite 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)
- DEN160044: Acumen Hypotension Prediction Index (HPI) Feature Software, Edwards Lifesciences, LLC (2018) Summary page 4.
- K183646: Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure, Edwards Lifeciences, LLC (2019) Summary page 4.
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module, Edwards Lifesciences, LLC (2019) Summary page 4.

## Most influential descendants
- K231038: Global Hypoperfusion Index (GHI) Algorithm (2023), 6 descendants of its own
- 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
- K233253: eCARTv5 Clinical Deterioration Suite (“eCART”) (2024), 1 descendant of its own

## Indications for use
CLEWICU provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. CLEWICU is intended for use with intensive care unit (ICU) patients 18 years and over. CLEWICU 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 CLEWICU predictions.

Source page: https://510kreport.com/device/K200717
Methodology: https://510kreport.com/methodology