# K233216: CLEWICU System

- Pathway: 510(k) (Traditional)
- Applicant: Clew Medical, Ltd.
- Decided: Jan 13, 2024 after 107 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: 27 generations back to K941811 (1994). 240 ancestors in all.
No later device cites it as a predicate yet.
1 of 241 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200717: CLEWICU System (ClewICUServer and ClewICUnitor), Clew Medical, Ltd. (2021) Summary page 5.

## Indications for use
CLEWICU provides the clinician with physiological insight into a patient’s likelihood of future hemodynamic instability. CLEWICU is intended for use in hospital critical care settings for 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/K233216
Methodology: https://510kreport.com/methodology