510(k) Report

510(k) · Cleared

Cleared

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

K994331510(k) SpecialCleared Jan 21, 200029-day reviewClass II21 CFR 870.2800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Vascular · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Cleared on Jan 21, 2000 after a 29-day review. The FDA summary names its predicate without a number. 90 later devices descend from it.

Decided
Jan 21, 2000
Review
29 days
Class
Class II
Product code
MXC
Recalls
None
Predicates
0

90 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2008: 2 descendants cleared2009: 4 descendants cleared2015: 4 descendants cleared2014: 5 descendants cleared2011: 3 descendants cleared2020: 4 descendants cleared2012: 4 descendants cleared2010: 2 descendants cleared2017: 9 descendants cleared2016: 5 descendants cleared2022: 4 descendants cleared2021: 5 descendants cleared2018: 2 descendants cleared2019: 6 descendants cleared2023: 10 descendants cleared2025: 5 descendants cleared2024: 6 descendants cleared2026: 6 descendants cleared200020052010201520202025
  1. This deviceK994331 Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted…Medtronic Vascular · 2000
  2. Descendant · cites it directly · 58 of its ownK081365 SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model…St Jude Medical · 2008 · Recalled
  3. Descendant · 2 generations on · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  4. Descendant · cites it directly · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  5. Descendant · 3 generations on · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  6. Descendant · 4 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011

Showing 5 of 90 descendants. See all descendants

Descendants cleared per year

2007: 42008: 22009: 42010: 22011: 32012: 42014: 52015: 42016: 52017: 92018: 22019: 62020: 42021: 52022: 42023: 102024: 62025: 52026: 6
2007high 10 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 90 · See all
  • K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient ActivatorSt Jude Medical · 2008 · cites it directly58descendants
  • K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · 2 generations on40descendants
  • K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · cites it directly40descendants
  • K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · 3 generations on38descendants
  • K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 4 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994331Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and…Medtronic Vascular2000—
+1K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient…St Jude Medical20081
+2K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.2009—
+1K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
+3K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)…Corventis, Inc.2009—
+4K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200740
200820
200940
201020
201130
201240
201450
201540
201650
201790
201820
201960
202040
202150
202240
2023100
202460
202550
202660
FIG. 1 — Lineage of K994331, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MXC device

  1. #1 K230286 Assert-IQ™ Insertable Cardiac Monitorscore 9.5 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Reveal ILR system
Named without a submission number
—

What descends from it? (90)

See all 90

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient ActivatorSt Jude Medical200858
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740
K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730
K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc.20073

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K081365 (St Jude Medical, 2008) has gone furthest, with 58 descendants of its own.

How does its category compare?

All MXC devices

MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MXC

1in 2023

2007: 22008: 12009: 22010: 12012: 22014: 12017: 22019: 32020: 32021: 12023: 1
2007high 3 (2019) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MXC

64in 2020

2019: 58 days median2020: 64 days median
2007high 64 (2020) · low 58 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MXC

1in 2018

2011: 12018: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MXC

1,105in 2025

2008: 32009: 122010: 142011: 212012: 302013: 1442014: 5982015: 2352016: 1942017: 2262018: 1,8192019: 1,5932020: 1,1002021: 8322022: 6282023: 8282024: 9752025: 1,105
2007high 1,819 (2018) · low 0 (2007)2025

MAUDE reports naming product code MXC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—03
20092—012
20101—014
20110—121
20122—030
20130—0144
20141—0598
20150—0235
20160—0194
20172—0226
20180—11,819
201935801,593
202036401,100
20211—0832
20220—0628
20231—0828
20240—0975
20250—01,105
20260—0—

What is it indicated for?

The Medtronic Reveal Plus Insertable Loop Recorder is an implantable patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Medtronic Vascular

1,057 FDA decisions under this applicant name. See the company

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  • P160043/S095Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S094Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026
  • P160043/S093Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S092Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026

Recent decisions in MXC

The MXC category page

  • K230286Assert-IQ™ Insertable Cardiac MonitorAbbott Medical · 2023
  • K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2021
  • K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020
  • K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020
  • K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical) · 2020

https://510kreport.com/device/K994331 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994331: Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994331

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026