Epic Systems Receives 510(k) Clearance for Deterioration Index Version 2
The latest version of Epic's predictive algorithm for patient decline has been deemed substantially equivalent, allowing its broader clinical use as a Class II device.
ProjMed Editorial Desk·Oct 3, 2026·3 min read·Evidence A
Epic Systems Corporation has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Deterioration Index Version 2. The clearance, announced on September 18, 2026, classifies the software as a Class II medical device, making it available for clinical use.
This clearance marks the second iteration of Epic's Deterioration Index to navigate the regulatory pathway, with the FDA determining the device to be substantially equivalent to a predicate device. The review was conducted under the Cardiovascular advisory committee.
Device Specifics
The Deterioration Index Version 2 falls under product code QNL, which typically pertains to software for patient physiological parameter calculation and display. This designation indicates its role in processing clinical data to identify trends or indicators of patient decline.
Regulated under 21 CFR 870.2210, the device is intended to provide clinicians with an automated assessment tool. While the specific data inputs and algorithm details are not publicly detailed in the clearance summary, such systems generally leverage electronic health record (EHR) data to calculate risk scores for adverse patient events.
The FDA's 'substantially equivalent' determination allows for market entry based on comparability to existing devices, without requiring new clinical trials to demonstrate safety and effectiveness for its intended use.
Regulatory Context
This Traditional 510(k) clearance process required Epic Systems to submit a detailed summary to the FDA demonstrating that the Deterioration Index Version 2 is as safe and effective as a legally marketed predicate device. This pathway is standard for many Class II medical devices.
Further details regarding the specific claims, performance data, or integration aspects of Deterioration Index Version 2 have not been publicly disclosed beyond the FDA's clearance record. The regulatory filing indicates an expansion or refinement of the original index, suggesting ongoing development in predictive analytics within clinical decision support.
