Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)— 510(k) K253196
Substantially EquivalentMidmark 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. Device class: 2.
Summary
Midmark's 800 Digital Vital Signs Device is listed in four models: 1-300-0100, 1-300-0200, 1-300-0300, and 1-300-0400. It's filed under MWI, patient physiological monitors without arrhythmia detection or alarms, and the record doesn't say how the models differ.
Class II, 21 CFR 870.2300. Cardiovascular is both the classification panel and the review panel. The submission was a Traditional 510(k).
Midmark filed from Versailles, Ohio. The decision came 259 calendar days after receipt (September 26, 2025 to June 12, 2026).
Clearance details
- Applicant
- Midmark Corporation
- Product code
- Product code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Versailles, OH, US
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Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . 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.