Cleared Traditional

K861375 - MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS

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

K861375 · Sharp Electronics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K861375

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.

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 905
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K861375.
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR
K861504 · Fukuda Denshi USA, Inc. · Aug 1986
AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202
K855127 · Spacelabs, Inc. · Aug 1986
NEOGUARD ECG ELECTRODES
K861364 · Cas Medical Systems, Inc. · Aug 1986
PREGELLED INFANT DISPOSABLE ECG ELECTRODE
K862756 · Labeltape Meditect, Inc. · Aug 1986
LIFESTAT 100
K853561 · Physio-Control Corp. · Jun 1986
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · Mennen Medical, Inc. · Jun 1986