510(k) · Cleared
ClearedAssert-IQ (DM5100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Cleared on Dec 18, 2025 as substantially equivalent to K251221 (Abbott, 2025) after a 36-day review. Its family tree reaches back 7 generations to 2019.
- Decided
- Dec 18, 2025
- Review
- 36 days
- Class
- Class II
- Product code
- MXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K190295 (2019). No later device cites it as a predicate yet.
- Root · 7 generations backK190295 Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2019
- 6 generations backK192593 Confirm Rx Insertable Cardiac MonitorAbbott · 2019
- 5 generations backK193310 myMerlin Mobile Application (Android), myMerlin Mobile Application…Abbott (St. Jude Medical) · 2020
- 4 generations backK202888 Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020
- 3 generations backK212206 Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2021
- 2 generations backK230286 Assert-IQ™ Insertable Cardiac MonitorAbbott Medical · 2023
- 1 generation backK251221 Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500)…Abbott · 2025
- This deviceK253516 Assert-IQ (DM5100)Abbott Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2019 | — |
| −6 | K192593 | Confirm Rx Insertable Cardiac Monitor | Abbott | 2019 | — |
| −5 | K193310 | myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) | Abbott (St. Jude Medical) | 2020 | — |
| −4 | K202888 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2020 | — |
| −3 | K212206 | Jot Dx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | 2021 | — |
| −2 | K230286 | Assert-IQ™ Insertable Cardiac Monitor | Abbott Medical | 2023 | — |
| −1 | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | 2025 | — |
| 0 (this device) | K253516 | Assert-IQ (DM5100) | Abbott Medical | 2025 | — |
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 MXD? 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 MXD device
- #1 K262735 LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)score 16.7 · 17 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 |
|---|---|---|---|
| * | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Summary page 5…MXD Classification: Class II Classification Panel: Cardiovascular Legally Marketed Device to Which Substantial Equivalence is Claimed 510(k) K251221 Assert-IQ™ Insertable Cardiac Monitor System Powered by AI Indications for Use There are no changes to the Indications f… | 2025 |
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 6 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All MXD devicesMXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MXD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXD
36in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXD
5so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXD
3,384in 2025
MAUDE reports naming product code MXD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 63 | 0 | 21 |
| 2017 | 4 | 52 | 0 | 37 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 1 | — | 0 | 70 |
| 2020 | 4 | 127 | 0 | 228 |
| 2021 | 4 | 57 | 0 | 694 |
| 2022 | 2 | — | 1 | 1,362 |
| 2023 | 6 | 76 | 1 | 1,766 |
| 2024 | 1 | — | 1 | 3,019 |
| 2025 | 3 | 36 | 0 | 3,384 |
| 2026 | 2 | — | 5 | — |
What is it indicated for?
The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ™ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation…
Read the full statement (107 words)
The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ™ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ™ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ™ 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/K253516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253516: Assert-IQ (DM5100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253516
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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