Cleared Special

SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES (K082520) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082520 · Mallinckrodt Medical · Anesthesiology device
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Oct 2008
Decision
30d
Days
Class 2
Risk

K082520 is an FDA 510(k) clearance for the SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Medical (Boulder, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mallinckrodt Medical devices

Submission Details

510(k) Number K082520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date October 02, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 139d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 37
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K082520.
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
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
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003