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 Apr 10, 2019 after a 58-day review. The FDA summary names no predicate by number. 8 later devices descend from it.
- Decided
- Apr 10, 2019
- Review
- 58 days
- Class
- Class II
- Product code
- MXC
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK190295 Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2019
- Descendant · cites it directly · 7 of its ownK192593 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
- Descendant · 2 generations on · 6 of its ownK193310 myMerlin Mobile Application (Android), myMerlin Mobile Application…Abbott (St. Jude Medical) · 2020
- Descendant · 3 generations on · 4 of its ownK202888 Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020
- Descendant · 4 generations on · 3 of its ownK212206 Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2021
- Descendant · 5 generations on · 2 of its ownK230286 Assert-IQ™ Insertable Cardiac MonitorAbbott Medical · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192593Confirm Rx Insertable Cardiac MonitorAbbott · 2019 · cites it directly7descendants
- K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical) · 2020 · 2 generations on6descendants
- K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020 · 3 generations on4descendants
- K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2021 · 4 generations on3descendants
- K230286Assert-IQ™ Insertable Cardiac MonitorAbbott Medical · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2019 | — |
| +1 | K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019 | — |
| +2 | K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | 2020 | — |
| +3 | K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020 | — |
| +4 | K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2021 | — |
| +5 | K230286 | Assert-IQ™ Insertable Cardiac Monitor | Abbott Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192593 | Confirm Rx Insertable Cardiac Monitor | 2019 | 7 |
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?
- Of its descendants, K192593 (Abbott, 2019) has gone furthest, with 7 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. 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 | — |
https://510kreport.com/device/K190295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190295: 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/K190295
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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