Cleared Traditional

K260008 - Deterioration Index Version 2

K260008 is an FDA 510(k) clearance for Deterioration Index Version 2, manufactured by Epic Systems Corporation. The device is a Class 2 Cardiovascular device with product code QNL cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K260008 · Epic Systems Corporation · Cardiovascular device
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Sep 2026
Decision
259d
Days
Class 2
Risk

K260008 is an FDA 510(k) clearance for the Deterioration Index Version 2. Classified as Medium-term Adjunctive Predictive Cardiovascular Indicator (product code QNL), Class II - Special Controls.

Submitted by Epic Systems Corporation (Verona, US). The FDA issued a Cleared decision on September 18, 2026 after a review of 259 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Epic Systems Corporation devices

FDA 510(k) Submission Details - K260008

510(k) Number K260008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2026
Decision Date September 18, 2026
Days to Decision 259 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QNL Device Classification - Class 2, Special Controls

Product Code QNL Medium-term Adjunctive Predictive Cardiovascular Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2210
Definition The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events Within A Defined Medium-term Period. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QNL Medium-term Adjunctive Predictive Cardiovascular Indicator

Devices cleared under the same product code (QNL) and FDA review panel - the closest regulatory comparables to K260008.
eCARTv5 Clinical Deterioration Suite (“eCART”)
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K200717 · Clew Medical , Ltd. · Jan 2021