# K163407: Confirm Rx Insertable Cardiac Monitor (ICM) System

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Inc.
- Decided: Sep 29, 2017 after 298 days
- Product code: MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K864889 (1987). 62 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133481: SJM Confirm Implantable Cardiac Monitor (Icm), St. Jude Medical, Inc. (2014) Summary page 4.
- K132649: Reveal Linq Insertable Cardiac Monitor, Medtronic, Inc. (2014) Summary page 4.

## Most influential descendants
- K182981: Confirm Rx Insertable Cardiac Monitor (2019), 0 descendants of its own
- K173232: myMerlin (TM) Mobile Application Model APP1001 (2017), 0 descendants of its own

## Recalls of this device
- Nov 19, 2018 · Class II · Z-1220-2019: The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
- Apr 16, 2018 · Class II · Z-2335-2018: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Inserta
- Apr 16, 2018 · Class II · Z-2334-2018: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Inserta
- Apr 13, 2018 · Class II · Z-0808-2020: Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.

## Indications for use
The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx ICM has not been specifically tested for pediatric use.

Source page: https://510kreport.com/device/K163407
Methodology: https://510kreport.com/methodology