# K193310: myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott (St. Jude Medical)
- Decided: Mar 17, 2020 after 109 days
- Product code: MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K190295 (2019). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192593: Confirm Rx Insertable Cardiac Monitor, Abbott (2019) Summary page 4.

## Most influential descendants
- K202888: Confirm Rx Insertable Cardiac Monitor (2020), 4 descendants of its own
- K212206: Jot Dx Insertable Cardiac Monitor (2021), 3 descendants of its own
- K230286: Assert-IQ™ Insertable Cardiac Monitor (2023), 2 descendants of its own
- K251221: Assert-IQ  (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (2025), 1 descendant of its own
- K253516: Assert-IQ (DM5100) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K193310
Methodology: https://510kreport.com/methodology