Cleared Traditional

K920877 - THE KEYSTONE SYSTEM

K920877 is an FDA 510(k) clearance for THE KEYSTONE SYSTEM, manufactured by S & M Instrument Co.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K920877

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.

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 150
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K920877.
ESCORT SPIROMETER
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K920246 · Sensor Medics Corp. · Apr 1992
AIRWAY THERMISTOR
K914219 · Synectics-Dantec · Feb 1992