Cleared Traditional

K101439 - CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101439 · Codonics, Inc. · Anesthesiology device
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Feb 2011
Decision
259d
Days
Class 2
Risk

K101439 is an FDA 510(k) clearance for the CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Codonics, Inc. (Middleburg Heights, US). The FDA issued a Cleared decision on February 7, 2011 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Codonics, Inc. devices

Submission Details

510(k) Number K101439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2010
Decision Date February 07, 2011
Days to Decision 259 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
120d slower than avg
Panel avg: 139d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 186
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K101439.
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