Cleared Traditional

K850830 - SHARP DIGITAL BP MONITOR MB-371H

K850830 is the FDA 510(k) clearance for SHARP DIGITAL BP MONITOR MB-371H by Sharp Electronics Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K850830 · Sharp Electronics Corp. · Cardiovascular device
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Jun 1985
Decision
127d
Days
Class 2
Risk

K850830 is an FDA 510(k) clearance for the SHARP DIGITAL BP MONITOR MB-371H. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Sharp Electronics Corp. (Paramus, US). The FDA issued a Cleared decision on June 13, 1985 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sharp Electronics Corp. devices

Submission Details

510(k) Number K850830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1985
Decision Date June 13, 1985
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 529
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