Cleared Traditional

K812409 - SPHYGMOMANOMETER

K812409 is the FDA 510(k) clearance for SPHYGMOMANOMETER by Somatronix Research Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K812409 · Somatronix Research Corp. · Cardiovascular device
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Nov 1981
Decision
73d
Days
Class 2
Risk

K812409 is an FDA 510(k) clearance for the SPHYGMOMANOMETER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Somatronix Research Corp. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 73 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 Somatronix Research Corp. devices

Submission Details

510(k) Number K812409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1981
Decision Date November 02, 1981
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
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 K812409.
TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER
K820135 · Sybron Corp. · Mar 1982
DIGITAL BLOOD PRESSURE UNIT
K813385 · Conphar, Inc. · Jan 1982
DINAMAP ADULT/PED./NEONATAL VITAL SIGNS
K813527 · Critikon Company, LLC · Jan 1982
NIVP MONITOR
K812259 · Datascope Corp. · Sep 1981
CONPHAR CHECKMATE SPHYGMOMANOMETER
K801187 · Conphar, Inc. · Jun 1980
MODEL 1978 PRESSUROMETER III AMBULATORY
K792075 · Del Mar Avionics · Dec 1979