Cleared Traditional

K861375 - MODEL MB-500 & MB-600 BLOOD PRESSURE MO...

K861375 is the FDA 510(k) clearance for MODEL MB-500 & MB-600 BLOOD PRESSURE MO... by Sharp Electronics Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K861375 · Sharp Electronics Corp. · Cardiovascular device
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Aug 1986
Decision
191d
Days
Class 2
Risk

K861375 is an FDA 510(k) clearance for the MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS. 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 August 6, 1986 after a review of 191 days - an extended review 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: 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 K861375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1986
Decision Date August 06, 1986
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
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
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K861375.
MODIFIED LIFESTAT 200
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K855127 · Spacelabs, Inc. · Aug 1986
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K853561 · Physio-Control Corp. · Jun 1986
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · Mennen Medical, Inc. · Jun 1986
DINAMAP VITAL SIGNS MONITOR MODEL 8100
K854434 · Critikon Company, LLC · May 1986