# K253529: Peerbridge COR MDx (Cor MDx)

- Pathway: 510(k) (Abbreviated)
- Applicant: Peerbridge Health, Inc.
- Decided: Sep 4, 2026 after 295 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- 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: 8 generations back to K963725 (1997). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171936: Peerbridge Cor (TM) System, Peerbridge Health, Inc. (2017) Summary page 5.

## Indications for use
The Peerbridge Cor MDx device is a retrospective ambulatory electrocardiogram (ECG) recorder with a patient-activated event button, intended to record external ECG data for up to fourteen (14) days. It is indicated for use on adult patients eighteen (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. Recorded ECG data is provided for manual retrospective review and interpretation by qualified clinical personnel following the wear period. The Cor MDx device does not perform automated arrhythmia detection, real-time analysis, or diagnostic interpretation. The Cor MDx device itself is only intended for manual interpretation and is not intended for ST segment analysis, ischemia detection, or myocardial infarction detection.

Source page: https://510kreport.com/device/K253529
Methodology: https://510kreport.com/methodology