# K260008: Deterioration Index Version 2

- Pathway: 510(k) (Traditional)
- Applicant: Epic Systems Corporation
- Decided: Sep 18, 2026 after 259 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). 241 ancestors in all.
No later device cites it as a predicate yet.
1 of 242 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233253: eCARTv5 Clinical Deterioration Suite (“eCART”), Agilemd, Inc. (2024) Summary page 5.

## Indications for use
Deterioration Index Version 2 is software that calculates the risk of patient deterioration, defined as the patient experiencing an escalation of care (a transfer to the ICU, a rapid response team call, or a code) or mortality. Deterioration Index Version 2 is for use with adult patients aged 18 or older who are admitted to an inpatient unit, observation unit, or on observation status in the emergency department of a hospital. The software is not for use with patients in a long-term care setting, operating room, post anesthesia care unit (PACU), labor and delivery unit, or for non-observation patients in an emergency department. The software is for use by trained healthcare professionals. Deterioration Index Version 2's risk score is calculated from Epic EHR data, such as vitals that have been documented for the patient. As clinical decision support software, Deterioration Index Version 2's risk score is intended to aid clinicians in identifying which patients are more likely to clinically deteriorate. Deterioration Index Version 2 provides additional information and does not replace the standard of care or clinical judgment. The device is not intended to serve as the primary determinant of health status for a patient, nor as a substitute for a healthcare professional's judgment and decision making. The device is not a primary diagnostic or treatment tool. Information provided by the device is not intended to be relied upon as the sole basis for decisions that have an impact that may cause death or an irreversible deterioration of a person's state of health.

Source page: https://510kreport.com/device/K260008
Methodology: https://510kreport.com/methodology