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The Tracker / September 2026 / K260008

510(k) cleared

Deterioration Index Version 2

Epic Systems Corporation · Sep 18, 2026 · K260008

FDA cleared the Deterioration Index Version 2 from Epic Systems Corporation on Sep 18, 2026 under K260008, a traditional 510(k). The device falls under product code QNL, Medium-Term Adjunctive Predictive Cardiovascular Indicator, regulated at 21 CFR 870.2210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 2, 2026. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Epic Systems Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260008?

K260008 is the FDA 510(k) for Deterioration Index Version 2, submitted by Epic Systems Corporation. FDA's decision date was Sep 18, 2026, under product code QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator).

Who makes the Deterioration Index Version 2?

Epic Systems Corporation, based in Verona, WI, is the applicant of record for K260008.

How long did the K260008 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Sep 18, 2026, 259 days later.

← All decisions in September 2026