# K202876: Confirm Rx Insertable Cardiac Monitor

- Pathway: 510(k) (Special)
- Applicant: Abbott (St. Jude Medical)
- Decided: Dec 1, 2020 after 64 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: 3 generations back to K190295 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193310: myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS), Abbott (St. Jude Medical) (2020) Summary page 4.

## Indications for use
The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as the following: 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/K202876
Methodology: https://510kreport.com/methodology