Cleared Special

K082520 - SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES

K082520 is an FDA 510(k) clearance for SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRA..., manufactured by Mallinckrodt Medical. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Special 510(k) pathway after a 30-day FDA review.

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

FDA 510(k) Submission Details - K082520

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

BTR Device Classification - Class 2, Special Controls

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 186
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K082520.
ENDOTRACHEAL TUBE
K080105 · Chilecom Medical Devices Co., Ltd. · Feb 2009
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
K080339 · Medsource International, LLC · Oct 2008
TRACHEOSCOPIC VENTILATION TUBE (TVT)
K082420 · Etview · Oct 2008
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
K081086 · Smiths Medical Asd, Inc. · Aug 2008
WELL LEAD REINFORCED ENDOTRACHEAL TUBE
K073383 · Well Lead Medical Instruments · Jul 2008
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE
K080821 · Kimberly-Clark Corp. · Apr 2008