510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011098Substantially Equivalent

Reveal Plus Insertable Loop Recorder System Model 9526 Implantable Recorder and Model 6191 Patient Activator

Medtronic, Inc., Minneapolis MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K011098 is the FDA 510(k) clearance record for REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR, a class II device, cleared for Medtronic Vascular on under FDA product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K011098.

Clearance record

Decision date
Received
(23 days to decision)
Product code
MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular 7000 Central Ave., NE, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code MXC

Trailing 12 months

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

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