Cleared Traditional

K831586 - CM-VII PHYSIOLOGIC ANALYZER

K831586 is an FDA 510(k) clearance for CM-VII PHYSIOLOGIC ANALYZER, manufactured by Cybermedic, Inc.. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K831586 · Cybermedic, Inc. · Anesthesiology device
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Mar 1984
Decision
307d
Days
Class 2
Risk

K831586 is an FDA 510(k) clearance for the CM-VII PHYSIOLOGIC ANALYZER. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Cybermedic, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1900 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cybermedic, Inc. devices

FDA 510(k) Submission Details - K831586

510(k) Number K831586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1983
Decision Date March 19, 1984
Days to Decision 307 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 140d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZM Device Classification - Class 2, Special Controls

Product Code BZM Calculator, Pulmonary Function Interpretor (diagnostic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1900
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZM Calculator, Pulmonary Function Interpretor (diagnostic)

All 16
Devices cleared under the same product code (BZM) and FDA review panel - the closest regulatory comparables to K831586.
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
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SPIROVISION
K864885 · Futuremed Div. of Future Impex Corp. · Jan 1987
PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
K861929 · Medical Graphics Corp. · Sep 1986
CARDIO-PULMONARY EXERCISE STRESS SYSTEM
K801495 · Medical Graphics Corp. · Jul 1980
PULMONARY LAB AUTOMATION SYSTEM
K801496 · Medical Graphics Corp. · Jul 1980
SCREENING COMPUTEO SC-20
K771371 · Cavitron Corp. · Aug 1977