510(k) · Cleared
ClearedSJM Confirm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cleared on Nov 28, 2012 as substantially equivalent to K081365 (St Jude Medical, 2008) and 1 other predicate after a 131-day review. Its family tree reaches back 7 generations to 1987. 4 later devices descend from it.
- Decided
- Nov 28, 2012
- Review
- 131 days
- Class
- Class II
- Product code
- MXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K864889 (1987). 55 ancestors in all, the oldest K832113 (1983). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 6 generations backK950264 MaglifeOdam · 1996
- 5 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 4 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 3 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 2 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 1 generation backK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- This deviceK122161 SJM ConfirmSt Jude Medical · 2012
- Descendant · cites it directly · 3 of its ownK133481 SJM Confirm Implantable Cardiac Monitor (Icm)St. Jude Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK182981 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −6 | K950264 | Maglife | Odam | 1996 | — |
| −5 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −4 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −3 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −2 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −1 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| 0 (this device) | K122161 | SJM Confirm | St Jude Medical | 2012 | — |
| +1 | K133481 | SJM Confirm Implantable Cardiac Monitor (Icm) | St. Jude Medical, Inc. | 2014 | — |
| +2 | K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | 2017 | 4 |
| +3 | K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019 | — |
| +3 | K173232 | myMerlin (TM) Mobile Application Model APP1001 | St Jude Medical | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
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 K230286 Assert-IQ™ Insertable Cardiac Monitorscore 9.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081365 | SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient ActivatorSummary page 1…800 Product Code: MXC Legally marketed devices to SIM Confirm® (Model DM2 100) Implantable Cardiac Monitor 5 10(k) which substantial K081365 equivalence is claimed: Medtronic Reveal DX Insertable Cardiac Monitor 5 10(k) K071655 Device Description: The SIM Con… | 2008 |
| * | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Summary page 1…2 100) Implantable Cardiac Monitor 5 10(k) which substantial K081365 equivalence is claimed: Medtronic Reveal DX Insertable Cardiac Monitor 5 10(k) K071655 Device Description: The SIM Confirm® Implantable Cardiac Monitor (MR Conditional) is a minimally invasive, implantable diagnos… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133481 | SJM Confirm Implantable Cardiac Monitor (Icm) | 2014 | 3 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 55 ancestors have 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 devicesMXC 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MXC
64in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXC
1,105in 2025
MAUDE reports naming product code MXC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 1 | — | 0 | 14 |
| 2011 | 0 | — | 1 | 21 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 144 |
| 2014 | 1 | — | 0 | 598 |
| 2015 | 0 | — | 0 | 235 |
| 2016 | 0 | — | 0 | 194 |
| 2017 | 2 | — | 0 | 226 |
| 2018 | 0 | — | 1 | 1,819 |
| 2019 | 3 | 58 | 0 | 1,593 |
| 2020 | 3 | 64 | 0 | 1,100 |
| 2021 | 1 | — | 0 | 832 |
| 2022 | 0 | — | 0 | 628 |
| 2023 | 1 | — | 0 | 828 |
| 2024 | 0 | — | 0 | 975 |
| 2025 | 0 | — | 0 | 1,105 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SJM Confirm® Implantable Cardiac Monitor 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.
https://510kreport.com/device/K122161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122161: SJM Confirm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122161
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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