510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K221203Substantially Equivalent

AHI System

Fifth Eye, Inc., Ann Arbor MI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221203 is the FDA 510(k) clearance record for AHI System, a class II device, cleared for Fifth Eye, Inc. on under FDA product code QNV (Adjunctive Hemodynamic Indicator With Decision Point). FDA's definition for product code QNV reads: "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...". FDA records list 3 510(k) clearances for Fifth Eye, Inc., from to . As of , FDA records show no recalls naming K221203.

Clearance record

Decision date
Received
(79 days to decision)
Product code
QNV Adjunctive Hemodynamic Indicator With Decision Point
Regulation
21 CFR 870.2220
Device class
Class II
Review panel
Cardiovascular
Applicant
Fifth Eye, Inc. 110 Miller Ave., Suite 300, Ann Arbor MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNV

Trailing 12 months

FDA records hold no clearances under product code QNV in the trailing twelve months.

FDA records show no clearances under product code QNV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260