Cleared Traditional

K860634 - PANASONIC BLOOD PRESSURE METER

K860634 is the FDA 510(k) clearance for PANASONIC BLOOD PRESSURE METER by Panasonic Co. Div. Matsu Elec. Corp. America. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K860634 · Panasonic Co. Div. Matsu Elec. Corp. America · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
131d
Days
Class 2
Risk

K860634 is an FDA 510(k) clearance for the PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Panasonic Co. Div. Matsu Elec. Corp. America (Secaucus, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 131 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 Panasonic Co. Div. Matsu Elec. Corp. America devices

Submission Details

510(k) Number K860634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1986
Decision Date July 01, 1986
Days to Decision 131 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 125d · This submission: 131d
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 537
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K860634.
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
LIFESTAT 100
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