# K133481: SJM Confirm Implantable Cardiac Monitor (Icm)

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Inc.
- Decided: May 28, 2014 after 196 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: 8 generations back to K864889 (1987). 59 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122161: SJM Confirm, St Jude Medical (2012) Summary page 2.
- K122090: SJM Confirm Implantable Cardiac Monitor, St. Jude Medical, Cardiac Rhythm Management Divisi (2012) Summary page 2.
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528, Medtronic, Inc. (2008) Summary page 2.
- K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator, St Jude Medical (2008) Summary page 2.

## Most influential descendants
- 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 1CM 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 other cardiac arrhythmias. The SJM Confirm 1CM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Source page: https://510kreport.com/device/K133481
Methodology: https://510kreport.com/methodology