510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K103764Substantially Equivalent

Reveal Xt Insertable Cardiac Monitor, Model 9529 and Reveal Dx Insertable Cardiac Monitor, Model 9528

Medtronic, Inc., Mounds View MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103764 is the FDA 510(k) clearance record for REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528, a class II device, cleared for Medtronic, Inc. on under FDA product code DSI (Detector And Alarm, Arrhythmia). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K103764.

Clearance record

Decision date
Received
(132 days to decision)
Product code
DSI Detector And Alarm, Arrhythmia
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic, Inc. 8200 Coral Sea St. N.E, Mounds View MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSI

Trailing 12 months
1 clearance under product code DSI in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSI, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260