Cleared Traditional

K864885 - SPIROVISION

K864885 is an FDA 510(k) clearance for SPIROVISION, manufactured by Futuremed Div. of Future Impex Corp.. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K864885 · Futuremed Div. of Future Impex Corp. · Anesthesiology device
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Jan 1987
Decision
34d
Days
Class 2
Risk

K864885 is an FDA 510(k) clearance for the SPIROVISION. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Futuremed Div. of Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on January 15, 1987 after a review of 34 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.

View all Futuremed Div. of Future Impex Corp. devices

FDA 510(k) Submission Details - K864885

510(k) Number K864885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date January 15, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 140d · This submission: 34d
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 9
Devices cleared under the same product code (BZM) and FDA review panel - the closest regulatory comparables to K864885.
PB100 DIAGNOSTIC SPIROMETER
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PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
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K801496 · Medical Graphics Corp. · Jul 1980