Cleared Traditional

K802412 - BLOOD PRESSURE UNIT MODEL 410

K802412 is an FDA 510(k) clearance for BLOOD PRESSURE UNIT MODEL 410, manufactured by Js & A Group. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K802412 · Js & A Group · Cardiovascular device
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Dec 1980
Decision
74d
Days
Class 2
Risk

K802412 is an FDA 510(k) clearance for the BLOOD PRESSURE UNIT MODEL 410. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Js & A Group (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 74 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 Js & A Group devices

FDA 510(k) Submission Details - K802412

510(k) Number K802412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1980
Decision Date December 16, 1980
Days to Decision 74 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
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 926
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K802412.
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
NON-INVASIVE, BLOOD PRESSURE MONITOR
K801657 · Biochem International, Inc. · Aug 1980
CONPHAR CHECKMATE SPHYGMOMANOMETER
K801187 · Conphar, Inc. · Jun 1980
DINAMAP RESEARCH MONITOR 1245
K800025 · Applied Medical Research · Feb 1980