Cleared Traditional

K832075 - ELECTRONIC BLOOD PRESS. METER-ZH-820P

K832075 is the FDA 510(k) clearance for ELECTRONIC BLOOD PRESS. METER-ZH-820P 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 45-day FDA review.

K832075 · Panasonic Co. Div. Matsu Elec. Corp. America · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
45d
Days
Class 2
Risk

K832075 is an FDA 510(k) clearance for the ELECTRONIC BLOOD PRESS. METER-ZH-820P. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Panasonic Co. Div. Matsu Elec. Corp. America (Nutley, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 45 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 Panasonic Co. Div. Matsu Elec. Corp. America devices

Submission Details

510(k) Number K832075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date August 12, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
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 K832075.
ALPHA NON-INVASIVE BP CARDULE
K832764 · Spacelabs, Inc. · Jan 1984
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · Critikon Company, LLC · Nov 1983
ACCU-SPHYG
K832060 · Olympic Medical Corp. · Oct 1983
LIFESTAT 200
K831232 · Physio-Control Corp. · Jul 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · Critikon Company, LLC · Jun 1983
CNIBP BLOOD PRESSURE MEASUREMENT SYS
K822055 · Ohio Medical Products · Nov 1982