# K122161: SJM Confirm

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Nov 28, 2012 after 131 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: 7 generations back to K864889 (1987). 55 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator, St Jude Medical (2008) Summary page 1.
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538, Medtronic, Inc. (2007) Summary page 1.

## Most influential descendants
- K133481: SJM Confirm Implantable Cardiac Monitor (Icm) (2014), 3 descendants of its own
- K163407: Confirm Rx Insertable Cardiac Monitor (ICM) System (2017), 2 descendants of its own
- K182981: Confirm Rx Insertable Cardiac Monitor (2019), 0 descendants of its own
- K173232: myMerlin (TM) Mobile Application Model APP1001 (2017), 0 descendants of its own

## Indications for use
The SJM Confirm® Implantable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: patients with clinical syndromes or situations at increased risk of cardiac arrhythmias patients who experience transient symptoms that may suggest a cardiac arrhythmia

Source page: https://510kreport.com/device/K122161
Methodology: https://510kreport.com/methodology