Cleared Special

K221203 - AHI System (FDA 510(k) Clearance)

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

K221203 · Fifth Eye, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
79d
Days
Class 2
Risk

K221203 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 July 14, 2022 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2220 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fifth Eye, Inc. devices

Submission Details

510(k) Number K221203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2022
Decision Date July 14, 2022
Days to Decision 79 days
Submission Type Special
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
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

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
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.