510(k) · Cleared
ClearedConfirm Rx Insertable Cardiac Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cleared on Mar 29, 2019 as substantially equivalent to K163407 (St. Jude Medical, Inc., 2017) after a 151-day review. Its family tree reaches back 11 generations to 1987.
- Decided
- Mar 29, 2019
- Review
- 151 days
- Class
- Class II
- Product code
- MXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K864889 (1987). 63 ancestors in all, the oldest K832113 (1983). No later device cites it as a predicate yet.
- Root · 11 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 7 generations between
- 3 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 2 generations backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- 1 generation backK163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017 · Recalled
- This deviceK182981 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
Show all 11 generations
- Root · 11 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 10 generations backK950264 MaglifeOdam · 1996
- 9 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 8 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 7 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 6 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 5 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 4 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- 3 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 2 generations backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- 1 generation backK163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. · 2017 · Recalled
- This deviceK182981 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −10 | K950264 | Maglife | Odam | 1996 | — |
| −9 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −8 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −7 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −6 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −5 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −4 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| −3 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| −2 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
| −1 | K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) System | St. Jude Medical, Inc. | 2017 | 4 |
| 0 (this device) | K182981 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019 | — |
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 |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) SystemSummary page 4…ally tested in pediatric patients below the age of 18 years. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 510(k) K163407: Confirm Rx™ Insertable Cardiac Monitor (ICM) System INDICATIONS FOR USE There are no changes to the Indications for Use as a re… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 63 ancestors have a recall of any class.
- 1 other device also cites its predicate K163407.
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. 2019, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182981: Confirm Rx Insertable 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/K182981
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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