510(k) K260008
K260008 is an FDA 510(k) premarket notification submitted by Epic Systems Corporation for the device "Deterioration Index Version 2". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator), a Class II device regulated under 21 CFR 870.2210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2026
- Date Received
- January 2, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Device Class
- Class II
- Regulation Number
- 870.2210
- Review Panel
- CV
- Submission Type
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.