Cleared Traditional

K894062 - ELECTRONIC BLOOD PRESSURE MONITORS

K894062 is an FDA 510(k) clearance for ELECTRONIC BLOOD PRESSURE MONITORS, manufactured by Hanson Scale Co.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K894062 · Hanson Scale Co. · Cardiovascular device
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Aug 1989
Decision
77d
Days
Class 2
Risk

K894062 is an FDA 510(k) clearance for the ELECTRONIC BLOOD PRESSURE MONITORS. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Hanson Scale Co. (Shubuta, US). The FDA issued a Cleared decision on August 24, 1989 after a review of 77 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 Hanson Scale Co. devices

FDA 510(k) Submission Details - K894062

510(k) Number K894062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date August 24, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
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 917
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K894062.
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