Cleared Traditional

K914260 - 4240 DYNAMIC BP/HEART RATE MONITOR

K914260 is an FDA 510(k) clearance for 4240 DYNAMIC BP/HEART RATE MONITOR, manufactured by Suntech Medical Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K914260 · Suntech Medical Instruments, Inc. · Cardiovascular device
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Sep 1992
Decision
347d
Days
Class 2
Risk

K914260 is an FDA 510(k) clearance for the 4240 DYNAMIC BP/HEART RATE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Suntech Medical Instruments, Inc. (Raleigh, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Suntech Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K914260

510(k) Number K914260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1991
Decision Date September 04, 1992
Days to Decision 347 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 125d · This submission: 347d
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 688
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K914260.
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K911645 · Datex Division Instrumentarium Corp. · Mar 1992
OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630
K911722 · Cas Medical Systems, Inc. · Jan 1992
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
K913523 · Omron Healthcare, Inc. · Nov 1991