Cleared Traditional

Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (K151381) - FDA 510(k) Clearance

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

K151381 · Covidien · Anesthesiology device
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Dec 2015
Decision
203d
Days
Class 2
Risk

K151381 is an FDA 510(k) clearance for the Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on December 11, 2015 after a review of 203 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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.

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Submission Details

510(k) Number K151381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2015
Decision Date December 11, 2015
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 38
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K151381.
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
K172208 · Nevap, Inc. · Feb 2018
Endotracheal tube
K170234 · Zhanjiang Star Enterprise Co., Ltd. · Jan 2018
IRRIS (Infra-Red-Red Intubation System)
K171411 · A.R Guide IN Medical , Ltd. · Jan 2018
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · Covidien · Apr 2009
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · C.R. Bard, Inc. · Mar 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K071365 · C.R. Bard, Inc. · Nov 2007