Cleared Traditional

K963131 - GRASEBY ANDERSEN'S, INTEGRITY S700

K963131 is an FDA 510(k) clearance for GRASEBY ANDERSEN'S, manufactured by Graseby Andersen. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K963131

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
Combination Product No
PCCP Authorized No
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.

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 122
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K963131.
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K953948 · Futuremed America, Inc. · Jun 1996