Cleared Traditional

K901308 - SPIRO ANALYZER MODEL ST 250

K901308 is an FDA 510(k) clearance for SPIRO ANALYZER MODEL ST 250, manufactured by Futuremed Div. of Future Impex Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K901308 · Futuremed Div. of Future Impex Corp. · Anesthesiology device
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Jul 1990
Decision
125d
Days
Class 2
Risk

K901308 is an FDA 510(k) clearance for the SPIRO ANALYZER MODEL ST 250. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Futuremed Div. of Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on July 23, 1990 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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. Standard predicate reliance. 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 Futuremed Div. of Future Impex Corp. devices

FDA 510(k) Submission Details - K901308

510(k) Number K901308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date July 23, 1990
Days to Decision 125 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
15d faster than avg
Panel avg: 140d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 65
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K901308.
VITALOGRAPH SPIROTRAC III
K912412 · Vitalograph , Ltd. · Oct 1991
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K904625 · Synectics-Dantec · Aug 1991
SPIROSIFT 500A
K904200 · Fukuda Denshi USA, Inc. · May 1991
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391 · Fukuda Denshi USA, Inc. · Apr 1990
SPIROSCAN 4000
K896924 · Brentwood Instruments, Inc. · Mar 1990
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990