Cleared Traditional

TRACOE smart Cuff Manager

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

About This 510(k) Submission

K152865 is an FDA 510(k) clearance for the TRACOE smart Cuff Manager, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Tracoe Medical GmbH (Nieder-Olm, DE). The FDA issued a Cleared decision on September 27, 2016, 363 days after receiving the submission on September 30, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K152865 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750