Cleared Traditional

K152778 - TRACOE Cuff Pressure Monitor

K152778 is an FDA 510(k) clearance for TRACOE Cuff Pressure Monitor, manufactured by Tracoe Medical GmbH. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 453-day FDA review.

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

K152778 is an FDA 510(k) clearance for the TRACOE Cuff Pressure Monitor. 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 December 21, 2016 after a review of 453 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Tracoe Medical GmbH devices

FDA 510(k) Submission Details - K152778

510(k) Number K152778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 140d · This submission: 453d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Ajw Technology Consultants, Inc.
Eva Schaeffer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BSK Cuff, Tracheal Tube, Inflatable

All 29
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K152778.
Accucuff Cuff Pressure Indicator
K182548 · Tianjin Medis Medical Device Co., Ltd. · Jan 2019
AG 100s
K180991 · Hospitech Respiration , Ltd. · Oct 2018
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
TRACOE smart Cuff Manager
K152865 · Tracoe Medical GmbH · Sep 2016
AnapnoGuard 100 Respiratory Guard System
K150157 · Hospitech Respiration , Ltd. · Feb 2016
IntelliCuff
K150893 · Hamilton Medical AG · Jan 2016