Cleared Traditional

DRAGER SPHYGMOMED (K840162) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840162 · Draeger Medical, Inc. · Cardiovascular device
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May 1984
Decision
138d
Days
Class 2
Risk

K840162 is an FDA 510(k) clearance for the DRAGER SPHYGMOMED. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Chadds Ford, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 138 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Draeger Medical, Inc. devices

Submission Details

510(k) Number K840162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1984
Decision Date May 30, 1984
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
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 270
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K840162.
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · Medtronic Vascular · Jun 1985
PHYSIOLOGICAL MONITOR 2100
K844353 · Datascope Corp. · Apr 1985
ACCUTORR CSM SYSTEM
K842538 · Datascope Corp. · Mar 1985
DIGITAL BLOOD PRESSURE UNIT
K813385 · Conphar, Inc. · Jan 1982
NIVP MONITOR
K812259 · Datascope Corp. · Sep 1981
CONPHAR CHECKMATE SPHYGMOMANOMETER
K801187 · Conphar, Inc. · Jun 1980