Cleared Traditional

K963131 - GRASEBY ANDERSEN'S

K963131 is the FDA 510(k) clearance for GRASEBY ANDERSEN'S by Graseby Andersen. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K963131 · Graseby Andersen · Anesthesiology device
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Feb 1997
Decision
186d
Days
Class 2
Risk

K963131 is an FDA 510(k) clearance for the GRASEBY ANDERSEN'S, INTEGRITY S700. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Graseby Andersen (Smyrna, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 186 days - an extended review 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: 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 Graseby Andersen devices

Submission Details

510(k) Number K963131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date February 14, 1997
Days to Decision 186 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 140d · This submission: 186d
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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