Cleared Traditional

K911264 - CALIBRATION KIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K911264 · S & W Medico Teknik · Anesthesiology device
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Aug 1991
Decision
144d
Days
Class 1
Risk

K911264 is an FDA 510(k) clearance for the CALIBRATION KIT. Classified as Gas, Calibration (specified Concentration) (product code BXK), Class I - General Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on August 2, 1991 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6400 - 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.

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Submission Details

510(k) Number K911264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date August 02, 1991
Days to Decision 144 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 139d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXK Gas, Calibration (specified Concentration)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.