# K171936: Peerbridge Cor (TM) System

- Pathway: 510(k) (Traditional)
- Applicant: Peerbridge Health, Inc.
- Decided: Sep 27, 2017 after 91 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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
Longest line of descent: 7 generations back to K963725 (1997). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143513: ZIO SR ECG Monitoring Service, iRhythm Technologies, Inc. (2015) Summary page 4.

## Most influential descendants
- K253529: Peerbridge COR MDx (Cor MDx) (2026), 0 descendants of its own

## Indications for use
The Peerbridge Cor™ System family of products is intended to capture and transmit symptomatic events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge Cor™ System contains a continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience.

Source page: https://510kreport.com/device/K171936
Methodology: https://510kreport.com/methodology