# K063035: Sleuth Implantable Ecg Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Transnoma Medical, Inc.
- Decided: Oct 1, 2007 after 367 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: 4 generations back to K871344 (1987). 14 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003667: Reveal Plus Insertable Loop Recorder, Medtronic Vascular (2001) Summary page 1.
- K994331: Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator, Medtronic Vascular (2000) Summary page 1.
- K972242: Reveal Insertable Loop Recorder (Ilr) System, Medtronic Vascular (1998) Summary page 1.
- K031466: Iqmark Digital Holter, Brentwood Medical Technology Corp. (2003) Summary page 2.

## Most influential descendants
- K073147: Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08 (2007), 2 descendants of its own
- K083828: Sleuth at Implantable Cardiac Monitoring System -6 CM  and 8CM Antenna, Personal Diagnostics Manager (PDM) Accessory Kit (2009), 1 descendant of its own
- K091206: Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic Manager (PDM) Accessory Kit, Model (2009), 0 descendants of its own

## Indications for use
The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG 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/K063035
Methodology: https://510kreport.com/methodology