Peerbridge COR MDx (Cor MDx)— 510(k) K253529

Name: FDA 510(k) clearance K253529
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

Peerbridge Health, Inc.

FDA 510(k) clearance K253529 for Peerbridge COR MDx (Cor MDx), Substantially Equivalent on 2026-09-04. Applicant: Peerbridge Health, Inc.. Device class: 2.

Clearance details

Applicant: Peerbridge Health, Inc.
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2025-11-13
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.