Cleared Traditional

K152865 - TRACOE smart Cuff Manager (FDA 510(k) Clearance)

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

K152865 · Tracoe Medical GmbH · Anesthesiology device
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Sep 2016
Decision
363d
Days
Class 2
Risk

K152865 is an FDA 510(k) clearance for the TRACOE smart Cuff Manager. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Tracoe Medical GmbH (Nieder-Olm, DE). The FDA issued a Cleared decision on September 27, 2016 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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.

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Submission Details

510(k) Number K152865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date September 27, 2016
Days to Decision 363 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
224d slower than avg
Panel avg: 139d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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.