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
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K233864Substantially Equivalent

ASSURE Wearable ECG

KESTRA Medical Technologies, Inc., Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233864 is the FDA 510(k) clearance record for ASSURE Wearable ECG, a class II device, cleared for Kestra Medical Technologies, Inc. on under FDA product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)). FDA records list one 510(k) clearance for Kestra Medical Technologies, Inc. As of , FDA records show no recalls naming K233864.

Clearance record

Decision date
Received
(153 days to decision)
Product code
MWJ Electrocardiograph, Ambulatory (Without Analysis)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Kestra Medical Technologies, Inc. 3933 Lake Washington Blvd. NE, Kirkland WA
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