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 (St. Jude Medical) · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cleared on Nov 23, 2020 as substantially equivalent to K193310 (Abbott (St. Jude Medical), 2020) after a 56-day review. Its family tree reaches back 3 generations to 2019. 4 later devices descend from it.
- Decided
- Nov 23, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- MXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K190295 (2019). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK190295 Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2019
- 2 generations backK192593 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
- 1 generation backK193310 myMerlin Mobile Application (Android), myMerlin Mobile Application…Abbott (St. Jude Medical) · 2020
- This deviceK202888 Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020
- Descendant · cites it directly · 3 of its ownK212206 Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2021
- Descendant · 2 generations on · 2 of its ownK230286 Assert-IQ™ Insertable Cardiac MonitorAbbott Medical · 2023
- Descendant · 3 generations on · 1 of its ownK251221 Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500)…Abbott · 2025
- Descendant · 4 generations on · 0 of its ownK253516 Assert-IQ (DM5100)Abbott Medical · 2025
Most influential descendants
Showing 4 of 4 · See all- K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2021 · cites it directly3descendants
- K230286Assert-IQ™ Insertable Cardiac MonitorAbbott Medical · 2023 · 2 generations on2descendants
- K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott · 2025 · 3 generations on1descendant
- K253516Assert-IQ (DM5100)Abbott Medical · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2019 | — |
| −2 | K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019 | — |
| −1 | K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | 2020 | — |
| 0 (this device) | K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020 | — |
| +1 | K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2021 | — |
| +2 | K230286 | Assert-IQ™ Insertable Cardiac Monitor | Abbott Medical | 2023 | — |
| +3 | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | 2025 | — |
| +4 | K253516 | Assert-IQ (DM5100) | Abbott Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Summary page 4…itor has not been specifically tested in pediatric patients. LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 510(k) K193310 Confirm Rx™ Insertable Cardiac Monitor System INDICATIONS FOR USE There are no changes to the Indications for Use as a result of… | 2020 |
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 |
|---|---|---|---|
| K212206 | Jot Dx Insertable Cardiac Monitor | 2021 | 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 1 year and passes through 2 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K212206 (Abbott (St. Jude Medical), 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K193310.
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. 2020, 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/K202888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202888: 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/K202888
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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