Cleared Traditional

K920877 - THE KEYSTONE SYSTEM

K920877 is the FDA 510(k) clearance for THE KEYSTONE SYSTEM by S & M Instrument Co.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K920877 · S & M Instrument Co. · Anesthesiology device
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Dec 1992
Decision
301d
Days
Class 2
Risk

K920877 is an FDA 510(k) clearance for the THE KEYSTONE SYSTEM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by S & M Instrument Co. (Doylestown, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 S & M Instrument Co. devices

Submission Details

510(k) Number K920877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1992
Decision Date December 23, 1992
Days to Decision 301 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 140d · This submission: 301d
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
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