510(k) Report

510(k) · Cleared

Recalled · 2011

SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator

K081365510(k) TraditionalCleared Aug 15, 200892-day reviewClass II21 CFR 870.2800Recalls 1

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

St Jude Medical · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Cleared on Aug 15, 2008 as substantially equivalent to K994331 (Medtronic Vascular, 2000) after a 92-day review. Its family tree reaches back 1 generation to 2000. 58 later devices descend from it. It has been recalled once.

Decided
Aug 15, 2008
Review
92 days
Class
Class II
Product code
MXC
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K994331 (2000). 58 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2012: 4 descendants cleared2009: 2 descendants cleared2014: 4 descendants cleared2010: 2 descendants cleared2017: 7 descendants cleared2016: 3 descendants cleared2011: 2 descendants cleared2018: 2 descendants cleared2019: 5 descendants cleared2020: 2 descendants cleared2023: 5 descendants cleared2022: 3 descendants cleared2025: 4 descendants cleared2024: 5 descendants cleared2026: 5 descendants cleared2021: 1 descendant clearedReference device: P910023 · Cadence (R) Tiered Therapy Defibrillation System · Abbott Medical · 1993 · recalledReference device: P880086 · Accent, Identity, Verity, Victory and Zephyr Pacemakers · Abbott Medical · 1989 · recalledK994331 · Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator · Medtronic Vascular · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 10 descendants4 generations forward: 7 descendants5 generations forward: 4 descendants6 generations forward: 5 descendants7 generations forward: 6 descendants8 generations forward: 5 descendants9 generations forward: 4 descendants10 generations forward: 4 descendants11 generations forward: 2 descendants K994331 · Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator · Medtronic Vascular · 20000+5+10
  1. Root · 1 generation backK994331 Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted…Medtronic Vascular · 2000
  2. This deviceK081365 SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model…St Jude Medical · 2008
  3. Descendant · cites it directly · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  4. Descendant · 2 generations on · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  5. Descendant · 3 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
  6. Descendant · 4 generations on · 24 of its ownK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
  7. Descendant · 5 generations on · 23 of its ownK133701 Nuvant MCT SystemCorventis, Inc. · 2014

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2009: 22010: 22011: 22012: 42014: 42015: 22016: 32017: 72018: 22019: 52020: 22021: 12022: 32023: 52024: 52025: 42026: 5
2009high 7 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 58 · See all
  • K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · cites it directly40descendants
  • K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · 2 generations on38descendants
  • K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 3 generations on30descendants
  • K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012 · 4 generations on24descendants
  • K133701Nuvant MCT SystemCorventis, Inc. · 2014 · 5 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K994331Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and…Medtronic Vascular2000—
0 (this device)K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient…St Jude Medical2008—
+1K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.2009—
+2K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)…Corventis, Inc.2009—
+3K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc.2011—
+4K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc.2012—
+5K133701Nuvant MCT SystemCorventis, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201020
201120
201240
201440
201520
201630
201770
201820
201950
202020
202110
202230
202350
202450
202540
202650
FIG. 1 — Lineage of K081365, 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 9.6 · 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
*K994331Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model…
Summary page 1
…fication: Class II, 21 CFR 870.2800, 21 CFR 870.2920 Legally marketed device to which your firm is claiming equivalence: Medtronic Reveal Plus ILR K994331 Device Description: The SJM Confirm Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring devi…
Medtronic Vascular2000—
†P910023Cadence (R) Tiered Therapy Defibrillation SystemAbbott Medical199340
†P880086Accent, Identity, Verity, Victory and Zephyr PacemakersAbbott Medical19899

Also cleared against K994331: 3 other devices →

What descends from it? (58)

See all 58

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

NumberDeviceApplicantDecidedDescendants
K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.200940
K132960BiomonitorBiotronik, Inc.201410
K143503BioMonitorBiotronik, Inc.20159
K122161SJM ConfirmSt Jude Medical20124
K122090SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi20124
K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 31, 2011Not classifiedZ-2733-2011Software change controlThe recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K090696 (Corventis, Inc., 2009) has gone furthest, with 40 descendants of its own.
  • 3 other devices also cite its predicate K994331.

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. 2008, this device’s year, is highlighted.

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 SJM Confirm ICM is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

* patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

* patients who experience transient symptoms that may suggest a cardiac arrhythmia

Indications for use as stated in the FDA summary.

Also cleared against K994331

3 other devices cite the same predicate.

  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007
  • K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007
  • K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007

More from St Jude Medical

304 FDA decisions under this applicant name. See the company

  • P960016/S094Ampere GeneratorSt Jude Medical · 2026
  • P130026/S102TactiSys Quartz Equipment; Ampere GeneratorSt Jude Medical · 2026
  • P130026/S100TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™St Jude Medical · 2026
  • P130026/S101TactiCath™ Ablation Catheter, Sensor Enabled™ (TactiCath™ SE)St Jude Medical · 2026
  • P130026/S099TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF…St Jude Medical · 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/K081365 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081365

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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