Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)— 510(k) K253196

Substantially Equivalent

Midmark Corporation

FDA 510(k) clearance K253196 for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400), Substantially Equivalent on 2026-06-12. Applicant: Midmark Corporation.

Clearance details

Applicant: Midmark Corporation
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2025-09-26
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Versailles, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.