Cleared Traditional

K781906 - BLOOD PRESSURE DEVICE, 400 SERIES

K781906 is an FDA 510(k) clearance for BLOOD PRESSURE DEVICE, manufactured by Med-Tek Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K781906 · Med-Tek Corp. · Cardiovascular device
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Nov 1978
Decision
3d
Days
Class 2
Risk

K781906 is an FDA 510(k) clearance for the BLOOD PRESSURE DEVICE, 400 SERIES. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Med-Tek Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1978 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Med-Tek Corp. devices

FDA 510(k) Submission Details - K781906

510(k) Number K781906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1978
Decision Date November 16, 1978
Days to Decision 3 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 125d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 926
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K781906.
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