Cleared Traditional

K864318 - THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM

K864318 is an FDA 510(k) clearance for THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM, manufactured by The Buddy Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K864318 · The Buddy Systems, Inc. · Cardiovascular device
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Mar 1987
Decision
137d
Days
Class 2
Risk

K864318 is an FDA 510(k) clearance for the THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by The Buddy Systems, Inc. (Northbrook, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 137 days - within the typical 510(k) review window.

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 The Buddy Systems, Inc. devices

FDA 510(k) Submission Details - K864318

510(k) Number K864318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date March 20, 1987
Days to Decision 137 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 125d · This submission: 137d
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 918
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K864318.
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
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K863891 · Quinton, Inc. · Feb 1987
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K861987 · Ohmeda Medical · Feb 1987