Cleared Traditional

K911871 - CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS

K911871 is an FDA 510(k) clearance for CARDIODYNE KINETORR/PC BLOOD PRESSURE M..., manufactured by Cardiodyne, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K911871

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.

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 929
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
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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