# K233253: eCARTv5 Clinical Deterioration Suite (“eCART”)

- Pathway: 510(k) (Traditional)
- Applicant: Agilemd, Inc.
- Decided: Jun 21, 2024 after 267 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.
1 later device descends from it; 1 cites it directly.
1 of 242 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.

## Most influential descendants
- K260008: Deterioration Index Version 2 (2026), 0 descendants of its own

## Indications for use
eCART is a software product that provides automated risk stratification and early warning for impending patient deterioration, signified as the composite outcome of death or ICU transfer. It is intended to be used on hospitalized ward patients 18 years of age or older by trained medical professionals. As a clinical decision support device, eCART’s risk score and trend analysis is intended to aid clinical teams in identifying which patients are most likely to clinically deteriorate. eCART provides additional information and does not replace the standard of care or clinical judgment. eCART scoring is initiated by the documentation of any vital sign on an adult ward patient. The device calculates risk only from validated EHR data, such as vitals that have been confirmed by a registered nurse (RN); unvalidated data streaming from monitors/devices will not be used until confirmed by a healthcare professional. The product predictions are for reference only and no therapeutic decisions should be made based solely on the eCART scores.

Source page: https://510kreport.com/device/K233253
Methodology: https://510kreport.com/methodology