Cleared Traditional

K861487 - ST-90 SPIRO ANALIZER

K861487 is an FDA 510(k) clearance for ST-90 SPIRO ANALIZER, manufactured by Future Impex Corp.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K861487 · Future Impex Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jun 1986
Decision
73d
Days
Class 2
Risk

K861487 is an FDA 510(k) clearance for the ST-90 SPIRO ANALIZER. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on June 23, 1986 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 - K861487

510(k) Number K861487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1986
Decision Date June 23, 1986
Days to Decision 73 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
67d faster than avg
Panel avg: 140d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 63
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K861487.
L.A.P. SPIROMETER
K864836 · Timeter Instrument Corp. · Mar 1987
PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
K864087 · Medical Associated Services, Inc. · Nov 1986
SPIROLOOP-PULMONARY EXERCISE SYSTEM
K863087 · Pneumedics, Inc. · Oct 1986
SPIROMETRY MODULE
K861486 · Medical Graphics Corp. · May 1986
SPIROMETER, MODEL TS-500 PART #SLZ7534
K855068 · Teledyne Avionics Div. of Teledyne · Feb 1986
SPIROMETER TS-400 SLZ 7547
K855069 · Teledyne Avionics Div. of Teledyne · Jan 1986
K861487 · ST-90 SPIRO ANALIZER
Download PDF Future Impex Corp.