Cleared Traditional

K800778 - DIGITAL ELECTRONIC B.P. MONITOR 2155

K800778 is an FDA 510(k) clearance for DIGITAL ELECTRONIC B.P. MONITOR 2155, manufactured by Sears, Roebuck & Co.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K800778 · Sears, Roebuck & Co. · Cardiovascular device
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Apr 1980
Decision
21d
Days
Class 2
Risk

K800778 is an FDA 510(k) clearance for the DIGITAL ELECTRONIC B.P. MONITOR 2155. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Sears, Roebuck & Co. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1980 after a review of 21 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 Sears, Roebuck & Co. devices

FDA 510(k) Submission Details - K800778

510(k) Number K800778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1980
Decision Date April 29, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
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 K800778.
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
MODEL 1978 PRESSUROMETER III AMBULATORY
K792075 · Del Mar Avionics · Dec 1979
DINAMAP MODEL 855
K791159 · Applied Medical Research · Jul 1979