# K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Aug 15, 2008 after 92 days
- Product code: MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994331 (2000). 1 ancestor in all.
58 later devices descend from it; 6 cite 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)
- K994331: Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator, Medtronic Vascular (2000) Summary page 1.

## Most influential descendants
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System (2009), 38 descendants of its own
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), 30 descendants of its own
- K113372: Nuvant, Mobilc Cardiac Telemetry (2012), 24 descendants of its own
- K133701: Nuvant MCT System (2014), 23 descendants of its own

## Recalls of this device
- Mar 31, 2011 · Not classified · Z-2733-2011: The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorit

## Indications for use
The SJM Confirm ICM 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/K081365
Methodology: https://510kreport.com/methodology