# K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Nov 7, 2008 after 71 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: 7 generations back to K864889 (1987). 55 ancestors in all.
28 later devices descend from it; 2 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)
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539), Medtronic, Inc. (2007) Summary page 1.
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538, Medtronic, Inc. (2007) Summary page 1.
- K020825: King of Hearts Express + AF Monitor, Card Guard Scientific Survival, Ltd. (2002) Summary page 1.

## Most influential descendants
- 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
- K162855: Reveal LINQ (2017), 11 descendants of its own

## Indications for use
The Reveal XT/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 such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia. The Reveal XT/DX 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 Patient Assistant Model 9539

Source page: https://510kreport.com/device/K082475
Methodology: https://510kreport.com/methodology