# K190295: Confirm Rx Insertable Cardiac Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Abbott (St. Jude Medical)
- Decided: Apr 10, 2019 after 58 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
No predicates in its family tree.
8 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K192593: Confirm Rx Insertable Cardiac Monitor (2019), 7 descendants of its own
- K193310: myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) (2020), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K190295
Methodology: https://510kreport.com/methodology