Cleared Traditional

K212219 - AHI System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212219 · Fifth Eye, Inc. · Cardiovascular device
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Dec 2021
Decision
140d
Days
Class 2
Risk

K212219 is an FDA 510(k) clearance for the AHI System. 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 Cleared decision on December 3, 2021 after a review of 140 days - within the typical 510(k) review window.

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 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 Fifth Eye, Inc. devices

Submission Details

510(k) Number K212219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2021
Decision Date December 03, 2021
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Consultant

Biologics Consulting Group
Donna-Bea Tillman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.