Cleared Traditional

K900247 - CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM

K900247 is an FDA 510(k) clearance for CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSU..., manufactured by Colin Medical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K900247 · Colin Medical Instruments Corp. · Cardiovascular device
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Jul 1990
Decision
181d
Days
Class 2
Risk

K900247 is an FDA 510(k) clearance for the CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Colin Medical Instruments Corp. (San Antonio, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 181 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 Colin Medical Instruments Corp. devices

FDA 510(k) Submission Details - K900247

510(k) Number K900247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date July 17, 1990
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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 768
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K900247.
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
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K896958 · Medical Data Electronics · Mar 1990
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K882955 · Kontron Instruments, Inc. · Jan 1990