# K972242: Reveal Insertable Loop Recorder (Ilr) System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jan 16, 1998 after 214 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Instromedix King of Hearts Express 3X: named in the summary without a submission number
- (no number) Medtronic Minix implantable pulse generator: named in the summary without a submission number

## Most influential descendants
- K063035: Sleuth Implantable Ecg Monitoring System (2007), 3 descendants of its own
- 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 Medtronic Model 9525 Reveal™ Insertable Loop Recorder is an implantable, patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia.

Source page: https://510kreport.com/device/K972242
Methodology: https://510kreport.com/methodology