Cleared Traditional

LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI (K853599) - FDA 510(k) Clearance

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

K853599 · Litton Datamedix · Cardiovascular device
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Mar 1986
Decision
206d
Days
Class 2
Risk

K853599 is an FDA 510(k) clearance for the LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Litton Datamedix (Sharon, US). The FDA issued a Cleared decision on March 21, 1986 after a review of 206 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 Litton Datamedix devices

Submission Details

510(k) Number K853599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1985
Decision Date March 21, 1986
Days to Decision 206 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 125d · This submission: 206d
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 255
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K853599.
MODIFIED STBP-680
K863891 · Quinton, Inc. · Feb 1987
NBP 488, TPR 488
K861856 · Siemens Medical Solutions USA, Inc. · Dec 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · Nihon Kohden America, Inc. · Apr 1986
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