510(k) Report

510(k) · Cleared

Cleared

SJM Confirm Implantable Cardiac Monitor

K122090510(k) TraditionalCleared Nov 15, 2012122-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

St. Jude Medical, Cardiac Rhythm Management Divisi · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Cleared on Nov 15, 2012 as substantially equivalent to K081365 (St Jude Medical, 2008) after a 122-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.

Decided
Nov 15, 2012
Review
122 days
Class
Class II
Product code
MXC
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K994331 (2000). 4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2017: 2 descendants cleared2019: 1 descendant clearedK994331 · Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator · Medtronic Vascular · 2000K081365 · SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator · St Jude Medical · 2008 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants K081365 · SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator · St Jude Medical · 2008 · recalledK994331 · Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator · Medtronic Vascular · 20000
  1. Root · 2 generations backK994331 Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted…Medtronic Vascular · 2000
  2. 1 generation backK081365 SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model…St Jude Medical · 2008 · Recalled
  3. This deviceK122090 SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  4. Descendant · cites it directly · 3 of its ownK133481 SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc. · 2014
  5. Descendant · 2 generations on · 2 of its ownK163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK182981 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
  7. Descendant · 3 generations on · 0 of its ownK173232 myMerlin (TM) Mobile Application Model APP1001St Jude Medical · 2017

Most influential descendants

Showing 4 of 4 · See all
  • K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc. · 2014 · cites it directly3descendants
  • K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017 · 2 generations on2descendants
  • K182981Confirm Rx Insertable Cardiac MonitorAbbott · 2019 · 3 generations on0descendants
  • K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K994331Reveal 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
0 (this device)K122090SJM Confirm Implantable Cardiac MonitorSt. Jude Medical, Cardiac Rhythm Management Divisi2012—
+1K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.2014—
+2K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.20174
+3K182981Confirm Rx Insertable Cardiac MonitorAbbott2019—
+3K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201720
201910
FIG. 1 — Lineage of K122090, 2000–2019Source: 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
*K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator
Summary page 1
…n: Class H1,21 CFR 870.2800 Legally marketed device to which your firm is claiming equivalence: SJM Confirm®R Implantable Cardiac Monitor System K08 1365 Device Description: The SJM Confirm®R Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring d…
St Jude Medical20081

Also cleared against K081365: 5 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.20143

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?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K133481 (St. Jude Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K081365.

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. 2012, 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® Implantable Cardiac Monitor is indicated for monitoring and diagnostic

evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations,

chest pain, syncope, shortness of breath, and patients who are at risk for other cardiac

arrhythmias.

Indications for use as stated in the FDA summary.

Also cleared against K081365

5 other devices cite the same predicate.

  • K143503BioMonitorBiotronik, Inc. · 2015
  • K132960BiomonitorBiotronik, Inc. · 2014
  • K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc. · 2014
  • K122161SJM ConfirmSt Jude Medical · 2012
  • K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009

More from St. Jude Medical, Cardiac Rhythm…

42 FDA decisions under this applicant name. See the company

  • K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  • K111943Agills PF Delivery SystemSt. Jude Medical, Cardiac Rhythm Management Divisi · 2011
  • K103250CPS Direct SL II Slittable Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi · 2011
  • K093858Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 2010

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/K122090 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122090: SJM Confirm Implantable Cardiac Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122090

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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