510(k) Report

510(k) · Cleared

Cleared

SJM Confirm Implantable Cardiac Monitor (Icm)

K133481510(k) TraditionalCleared May 28, 2014196-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, Inc. · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Cleared on May 28, 2014 as substantially equivalent to K122161 (St Jude Medical, 2012) and 3 other predicates after a 196-day review. Its family tree reaches back 8 generations to 1987. 3 later devices descend from it.

Decided
May 28, 2014
Review
196 days
Class
Class II
Product code
MXC
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K864889 (1987). 59 ancestors in all, the oldest K832113 (1983). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 2 other ancestors2008: 1 other ancestor2007: 1 other ancestor2002: 2 other ancestors2000: 3 other ancestors2005: 1 other ancestor2001: 3 other ancestors1999: 7 other ancestors1992: 2 other ancestors2004: 2 other ancestors2003: 1 other ancestor1998: 2 other ancestors1996: 3 other ancestors1995: 7 other ancestors1994: 3 other ancestors1986: 1 other ancestor1997: 2 other ancestors1993: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor1983: 1 other ancestor1987: 1 other ancestor2017: 2 descendants cleared2019: 1 descendant clearedK864889 · Omni-Trak · Invivo Research Labs, Inc. · 1987K950264 · Maglife · Odam · 1996K023195 · Maglife C/Maglife C Plus · Schiller Medical S.A. · 2003K040915 · Magnitude 3150M Mri Patient Monitor, Model 3150M · Invivo Research, Inc. · 2004×2: 2 generations cleared close together, K050399 (2005), K053462 (2006) K071641 · Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) · Medtronic, Inc. · 2007K082475 · Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 · Medtronic, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 5 other ancestors4 generations back: 9 other ancestors5 generations back: 12 other ancestors6 generations back: 15 other ancestors7 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K082475 · Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 · Medtronic, Inc. · 2008K071641 · Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) · Medtronic, Inc. · 2007K053462 · 3160 Mri Patient Monitoring System · Invivo Corporation · 2006 · recalledK050399 · Mri Compatible Patient Monitoring System, Model 3160 · Invivo Research, Inc. · 2005K040915 · Magnitude 3150M Mri Patient Monitor, Model 3150M · Invivo Research, Inc. · 2004K023195 · Maglife C/Maglife C Plus · Schiller Medical S.A. · 2003K950264 · Maglife · Odam · 1996K864889 · Omni-Trak · Invivo Research Labs, Inc. · 1987−50
  1. Root · 8 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
  2. 7 generations backK950264 MaglifeOdam · 1996
  3. 6 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
  4. 5 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
  5. 4 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
  6. 3 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
  7. 2 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  8. 1 generation backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
  9. This deviceK133481 SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc. · 2014
  10. Descendant · cites it directly · 2 of its ownK163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017 · Recalled
  11. Descendant · 2 generations on · 0 of its ownK182981 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
  12. Descendant · 2 generations on · 0 of its ownK173232 myMerlin (TM) Mobile Application Model APP1001St Jude Medical · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017 · cites it directly2descendants
  • K182981Confirm Rx Insertable Cardiac MonitorAbbott · 2019 · 2 generations on0descendants
  • K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K864889Omni-TrakInvivo Research Labs, Inc.1987—
−7K950264MaglifeOdam1996—
−6K023195Maglife C/Maglife C PlusSchiller Medical S.A.2003—
−5K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc.2004—
−4K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc.2005—
−3K0534623160 Mri Patient Monitoring SystemInvivo Corporation20062
−2K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
−1K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…Medtronic, Inc.2008—
0 (this device)K133481SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc.2014—
+1K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.20174
+2K182981Confirm Rx Insertable Cardiac MonitorAbbott2019—
+2K173232myMerlin (TM) Mobile Application Model APP1001St Jude Medical2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198610
198710
198810
198910
199010
199110
199220
199320
199430
199570
199630
199720
199820
199970
200030
200130
200220
200310
200420
200510
200710
200810
201220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201910
FIG. 1 — Lineage of K133481, 1987–2019Source: 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? (4)

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
*K122161SJM Confirm
Summary page 2
…510(k) PREMARKET NOTIFICATION SECTION 5 510(k) SUMMARY (CONT.) PREDICATE DEVICE(S) * St. Jude Medical, Inc. SIM Confirm (DM2100) [CM (K122161) " St. Jude Medical, Inc. SJM Confirm (DM2100) 1CM (K122090) * Medtronic, Inc. Reveal XT Insertable Cardiac Monitor (…
St Jude Medical2012—
*K122090SJM Confirm Implantable Cardiac Monitor
Summary page 2
…5 510(k) SUMMARY (CONT.) PREDICATE DEVICE(S) * St. Jude Medical, Inc. SIM Confirm (DM2100) [CM (K122161) " St. Jude Medical, Inc. SJM Confirm (DM2100) 1CM (K122090) * Medtronic, Inc. Reveal XT Insertable Cardiac Monitor (K082475) * St. Jude Medical, Inc. SIM Confirm (DM2100) [CM (…
St. Jude Medical, Cardiac Rhythm Management Divisi2012—
*K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…
Summary page 2
…, Inc. SIM Confirm (DM2100) [CM (K122161) " St. Jude Medical, Inc. SJM Confirm (DM2100) 1CM (K122090) * Medtronic, Inc. Reveal XT Insertable Cardiac Monitor (K082475) * St. Jude Medical, Inc. SIM Confirm (DM2100) [CM (K081365) INDICATIONS FOR USE The SJM Confirm h [CM is indicated for th…
Medtronic, Inc.2008—
*K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator
Summary page 2
…, Inc. SJM Confirm (DM2100) 1CM (K122090) * Medtronic, Inc. Reveal XT Insertable Cardiac Monitor (K082475) * St. Jude Medical, Inc. SIM Confirm (DM2100) [CM (K081365) INDICATIONS FOR USE The SJM Confirm h [CM is indicated for the monitoring and diagnostic evaluation of patients who experience…
St Jude Medical20081

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.20172

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 27 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
  • 4 of the 59 ancestors have a recall of any class.
  • Of its descendants, K163407 (St. Jude Medical, Inc., 2017) has gone furthest, with 2 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. 2014, 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 1CM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias.

The SJM Confirm 1CM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Indications for use as stated in the FDA summary.

More from St. Jude Medical, Inc.

353 FDA decisions under this applicant name. See the company

  • K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. · 2018
  • K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 20174 recalls
  • K161171PressureWire X GuidewireSt. Jude Medical, Inc. · 2016
  • K161102Nanostim Introducer KitSt. Jude Medical, Inc. · 2016
  • K160716The Nanostim Introducer KitSt. Jude Medical, Inc. · 2016

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/K133481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133481: SJM Confirm Implantable Cardiac Monitor (Icm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133481

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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