Cleared Traditional

K853190 - SUPERSPIRO

K853190 is an FDA 510(k) clearance for SUPERSPIRO, manufactured by Cdx Corp.. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K853190 · Cdx Corp. · Anesthesiology device
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Sep 1985
Decision
58d
Days
Class 2
Risk

K853190 is an FDA 510(k) clearance for the SUPERSPIRO. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Cdx Corp. (Aurora, US). The FDA issued a Cleared decision on September 26, 1985 after a review of 58 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 - K853190

510(k) Number K853190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date September 26, 1985
Days to Decision 58 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 140d · This submission: 58d
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 K853190.
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
K871711 · Medical Graphics Corp. · Sep 1987
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
K853190 · SUPERSPIRO
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