# K150117: Medtronic Patient Asistant

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: May 27, 2015 after 127 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: 9 generations back to K864889 (1987). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528, Medtronic, Inc. (2011) Summary page 4.

## Most influential descendants
- K190574: Patient Assistant Model PA97000 (2019), 0 descendants of its own

## Indications for use
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal Family of Insertable Cardiac Monitors (ICM) to initiate recording of cardiac event data in the implanted device memory.

Source page: https://510kreport.com/device/K150117
Methodology: https://510kreport.com/methodology