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
K101024Substantially Equivalent

Kenz Cardy302 Max

Suzuken Co., Ltd., Richardson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101024 is the FDA 510(k) clearance record for KENZ CARDY302 MAX, a class II device, cleared for Suzuken Co., Ltd. on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list 13 510(k) clearances for Suzuken Co., Ltd., from to . As of , FDA records show no recalls naming K101024.

Clearance record

Decision date
Received
(268 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Suzuken Co., Ltd. 1201 Richardson, Richardson TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWJ

Trailing 12 months
5 clearances under product code MWJ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20261
September 20262
October 20260