Cleared Traditional

K820300 - ELECTRONIC DIGITAL SPHYGMOMANOMETER

K820300 is the FDA 510(k) clearance for ELECTRONIC DIGITAL SPHYGMOMANOMETER by Copal, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K820300 · Copal, Inc. · Cardiovascular device
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Mar 1982
Decision
49d
Days
Class 2
Risk

K820300 is an FDA 510(k) clearance for the ELECTRONIC DIGITAL SPHYGMOMANOMETER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Copal, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982 after a review of 49 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 Copal, Inc. devices

Submission Details

510(k) Number K820300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1982
Decision Date March 25, 1982
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
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 544
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K820300.
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K821378 · Narco Scientific · Jul 1982
IVAC #1160 MULTIPLE VITAL SIGNS UNIT
K820569 · Y · Mar 1982
TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER
K820135 · Sybron Corp. · Mar 1982
DIGITAL BLOOD PRESSURE UNIT
K813385 · Conphar, Inc. · Jan 1982