Cleared Traditional

K791229 - CYBER DX 100

K791229 is an FDA 510(k) clearance for CYBER DX 100, manufactured by Cyber Diagnostics. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K791229 · Cyber Diagnostics · Anesthesiology device
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Jul 1979
Decision
21d
Days
Class 2
Risk

K791229 is an FDA 510(k) clearance for the CYBER DX 100. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Cyber Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K791229

510(k) Number K791229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1979
Decision Date July 30, 1979
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 140d · This submission: 21d
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 K791229.
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
K791229 · CYBER DX 100
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