Cleared Abbreviated

K253529 - Peerbridge COR MDx (Cor MDx)

K253529 is an FDA 510(k) clearance for Peerbridge COR MDx (Cor MDx), manufactured by Peerbridge Health, Inc.. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Abbreviated 510(k) pathway after a 295-day FDA review.

K253529 · Peerbridge Health, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
295d
Days
Class 2
Risk

K253529 is an FDA 510(k) clearance for the Peerbridge COR MDx (Cor MDx). Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Peerbridge Health, Inc. (New York, US). The FDA issued a Cleared decision on September 4, 2026 after a review of 295 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Peerbridge Health, Inc. devices

FDA 510(k) Submission Details - K253529

510(k) Number K253529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2025
Decision Date September 04, 2026
Days to Decision 295 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 125d · This submission: 295d
Pathway characteristics
Standards-based clearance path.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 59
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