Cleared Traditional

TRACOE Cuff Pressure Monitor

K152778 · Tracoe Medical GmbH · Anesthesiology
Dec 2016
Decision
453d
Days
Class 2
Risk

About This 510(k) Submission

K152778 is an FDA 510(k) clearance for the TRACOE Cuff Pressure Monitor, 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 December 21, 2016, 453 days after receiving the submission on September 25, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K152778 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2015
Decision Date December 21, 2016
Days to Decision 453 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