# K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Nov 21, 2007 after 156 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K864889 (1987). 53 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 84 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.
- K003667: Reveal Plus Insertable Loop Recorder, Medtronic Vascular (2001) Summary page 1.
- K042108: Vista Plus, Novacor (2005) Summary page 1.
- K992410: Actitrac, Individual Monitoring Systems, Inc. (1999) Summary page 1.
- K053462: 3160 Mri Patient Monitoring System, Invivo Corporation (2006) Summary page 1.

## Most influential descendants
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 (2011), 26 descendants of its own
- K132649: Reveal Linq Insertable Cardiac Monitor (2014), 23 descendants of its own
- K150614: Reveal LINQ (2015), 15 descendants of its own
- K160809: Reveal LINQ (2016), 12 descendants of its own

## Indications for use
The Reveal DX Insertable Cardiac Monitor 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 The Reveal Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor: • To verify whether the implanted device has detected a suspected arrhythmia or device related event.* * To initiate recording of cardiac event data in the implanted device memory, *only applicable to the Reveal XT PatientAssistant Model 9539

Source page: https://510kreport.com/device/K071655
Methodology: https://510kreport.com/methodology