# K994331: Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model 6191 Patient Activator

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Jan 21, 2000 after 29 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.
90 later devices descend from it; 4 cite it directly.
0 of 91 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) Reveal ILR system: named in the summary without a submission number

## Most influential descendants
- K081365: SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator (2008), 58 descendants of its own
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 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

## Indications for use
The Medtronic Reveal Plus 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/K994331
Methodology: https://510kreport.com/methodology