Cleared Traditional

K873817 - SPIRO ANALYZER ST-300

K873817 is the FDA 510(k) clearance for SPIRO ANALYZER ST-300 by Futuremed Div. of Future Impex Corp.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K873817 · Futuremed Div. of Future Impex Corp. · Anesthesiology device
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Dec 1987
Decision
72d
Days
Class 2
Risk

K873817 is an FDA 510(k) clearance for the SPIRO ANALYZER ST-300. 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 December 2, 1987 after a review of 72 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K873817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1987
Decision Date December 02, 1987
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 140d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K873817.
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K895253 · Welch Allyn, Inc. · Nov 1989
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K890522 · Puritan Bennett Corp. · Apr 1989
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985
SPIROMED 2
K851620 · Draeger Medical, Inc. · May 1985
BREATH METER
K810437 · Fred Sammons, Inc. · May 1981