# K091206: Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic Manager (PDM) Accessory Kit, Model

- Pathway: 510(k) (Special)
- Applicant: Transoma Medical
- Decided: May 18, 2009 after 24 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 K871344 (1987). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083828: Sleuth at Implantable Cardiac Monitoring System -6 CM  and 8CM Antenna, Personal Diagnostics Manager (PDM) Accessory Kit, Transoma (2009) Summary page 1.

## Indications for use
The Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECU and is indicated for: * 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/K091206
Methodology: https://510kreport.com/methodology