Cleared Traditional

MODIFIED DRAGER SPHYGMOMED (K862427) - FDA 510(k) Clearance

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

K862427 · Draeger Medical, Inc. · Cardiovascular device
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Mar 1987
Decision
270d
Days
Class 2
Risk

K862427 is an FDA 510(k) clearance for the MODIFIED DRAGER SPHYGMOMED. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on March 23, 1987 after a review of 270 days - an extended review 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: 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 K862427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date March 23, 1987
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
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 K862427.
OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
K880572 · Ohmeda Medical · May 1988
DORROS(TM) SMALL VESSEL PTA CATHETER
K870460 · C.R. Bard, Inc. · Jun 1987
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
K871363 · Quinton, Inc. · Jun 1987
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340
K864737 · Siemens Medical Solutions USA, Inc. · Mar 1987
MODIFIED STBP-680
K863891 · Quinton, Inc. · Feb 1987
2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
K861987 · Ohmeda Medical · Feb 1987