510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200052Unknown

KidneyIntelX.dkd

Renalytix Ai, Inc., New York NY / Direct, Unknown
FDA source (opens on fda.gov)

DEN200052 is the FDA 510(k) clearance record for KidneyIntelX.dkd, a class II device, cleared for Renalytix Ai, Inc. on under FDA product code QWZ (Prognostic Test For Assessment Of Chronic Kidney Disease Progression). FDA's definition for product code QWZ reads: "A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney...". FDA records list one 510(k) clearance for Renalytix Ai, Inc. As of , FDA records show no recalls naming DEN200052.

Clearance record

Decision date
Received
(1,037 days to decision)
Product code
QWZ Prognostic Test For Assessment Of Chronic Kidney Disease Progression
Regulation
21 CFR 862.1223
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Renalytix Ai, Inc. 1460 Broadway, New York NY
Third party review
No

Clearances, product code QWZ

Trailing 12 months

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

FDA records show no clearances under product code QWZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWZ, 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