Not Cleared Direct

DEN200022 - Analytic for Hemodynamic Instability (AHI) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200022 · Fifth Eye, Inc. · Cardiovascular device
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Mar 2021
Decision
332d
Days
Class 2
Risk

DEN200022 is an FDA 510(k) submission (not cleared) for the Analytic for Hemodynamic Instability (AHI). Classified as Adjunctive Hemodynamic Indicator With Decision Point (product code QNV), Class II - Special Controls.

Submitted by Fifth Eye, Inc. (Ann Arbor, US). The FDA issued a Not Cleared (DENG) decision on March 1, 2021 after a review of 332 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 332 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Fifth Eye, Inc. devices

Submission Details

510(k) Number DEN200022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 03, 2020
Decision Date March 01, 2021
Days to Decision 332 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 125d · This submission: 332d
Pathway characteristics

Device Classification

Product Code QNV Adjunctive Hemodynamic Indicator With Decision Point
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2220
Definition An Adjunctive Hemodynamic Indicator With Decision Point Is A Device That Identifies And Monitors Hemodynamic Condition(s) Of Interest And Provides Notifications At A Clinically Meaningful Decision Point. This Device Is Intended To Be Used Adjunctively Along With Other Monitoring And Patient Information.
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.