510(k) · Cleared
Recalled · Class II · 2018Confirm Rx Insertable Cardiac Monitor (ICM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Inc. · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cleared on Sep 29, 2017 as substantially equivalent to K133481 (St. Jude Medical, Inc., 2014) and 1 other predicate after a 298-day review. Its family tree reaches back 10 generations to 1987. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 29, 2017
- Review
- 298 days
- Class
- Class II
- Product code
- MXC
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 10 generations to K864889 (1987). 62 ancestors in all, the oldest K832113 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 6 generations between
- 3 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- 2 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 1 generation backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- This deviceK163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK182981 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
- Descendant · cites it directly · 0 of its ownK173232 myMerlin (TM) Mobile Application Model APP1001St Jude Medical · 2017
Show all 10 generations
- Root · 10 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 9 generations backK950264 MaglifeOdam · 1996
- 8 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 7 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 6 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 5 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 4 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 3 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- 2 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 1 generation backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- This deviceK163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −9 | K950264 | Maglife | Odam | 1996 | — |
| −8 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −7 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −6 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −5 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −4 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −3 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| −2 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| −1 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
| 0 (this device) | K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | 2017 | — |
| +1 | K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019 | — |
| +1 | 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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 9.6 · 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 |
|---|---|---|---|
| * | K133481 | SJM Confirm Implantable Cardiac Monitor (Icm)Summary page 4…ly tested in pediatric patients below the age of 18 years. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 510(k) K133481: SJM Confirm™ (Model DM2102) Implantable Cardiac Monitor 510(k) K132649: Medtronic Reveal LINQ™ (Model LNQ11) Insertable Cardiac… | 2014 |
| * | K132649 | Reveal Linq Insertable Cardiac MonitorSummary page 4…he age of 18 years. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 510(k) K133481: SJM Confirm™ (Model DM2102) Implantable Cardiac Monitor 510(k) K132649: Medtronic Reveal LINQ™ (Model LNQ11) Insertable Cardiac Monitor INDICATIONS FOR USE The Indications for Use for the Confirm Rx™… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2018 | Class II | Z-1220-2019 | Software design | The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. |
| Apr 16, 2018 | Class II | Z-2335-2018 | Nonconforming Material/Component | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices.… |
| Apr 16, 2018 | Class II | Z-2334-2018 | Nonconforming Material/Component | The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices.… |
| Apr 13, 2018 | Class II | Z-0808-2020 | Process control | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 62 ancestors have a recall of any class.
- Of its descendants, K182981 (Abbott, 2019) has gone furthest, with 0 descendants of its own.
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. 2017, 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 Confirm Rx™ ICM 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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
The Confirm Rx ICM has not been specifically tested for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163407: Confirm Rx Insertable Cardiac Monitor (ICM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163407
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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