Cleared Traditional

K911871 - CARDIODYNE KINETORR/PC BLOOD PRESSURE M...

K911871 is the FDA 510(k) clearance for CARDIODYNE KINETORR/PC BLOOD PRESSURE M... by Cardiodyne, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K911871 · Cardiodyne, Inc. · Cardiovascular device
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Nov 1991
Decision
195d
Days
Class 2
Risk

K911871 is an FDA 510(k) clearance for the CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Cardiodyne, Inc. (Brookline, US). The FDA issued a Cleared decision on November 7, 1991 after a review of 195 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 Cardiodyne, Inc. devices

Submission Details

510(k) Number K911871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date November 07, 1991
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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 548
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K911871.
BP PUMP
K921074 · Bio-Tek Instruments, Inc. · Oct 1992
NGM NIBP MODULE
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
BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP
K911351 · Biochem International, Inc. · Aug 1991
DIGITAL SPHYGMOIMANOMETER, MODEL UA-830
K911049 · A&D Engineering, Inc. · Aug 1991