Cleared Special

K113644 - PILOT TUBE REPAIR KIT

K113644 is an FDA 510(k) clearance for PILOT TUBE REPAIR KIT, manufactured by Instrumentation Industries, Inc.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Special 510(k) pathway after a 45-day FDA review.

K113644 · Instrumentation Industries, Inc. · Anesthesiology device
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Jan 2012
Decision
45d
Days
Class 2
Risk

K113644 is an FDA 510(k) clearance for the PILOT TUBE REPAIR KIT. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on January 26, 2012 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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 Instrumentation Industries, Inc. devices

FDA 510(k) Submission Details - K113644

510(k) Number K113644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2011
Decision Date January 26, 2012
Days to Decision 45 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
95d faster than avg
Panel avg: 140d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 Peers - BSK Cuff, Tracheal Tube, Inflatable

All 26
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K113644.
CUFF PILOT, SURE SEAL
K142103 · Teleflexmedical, Inc. · May 2015
AG GUFFILL
K122721 · Hospitech Respiration , Ltd. · May 2013
SPIRTIUS CUFF INFLATION SYRINGE
K112915 · Spiritus Technologies, LLC · May 2012
VENNER TRACHEAL SEAL MONITOR
K110631 · Venner Medical (Singapore) Pte, Ltd. · Jul 2011
CUFF SENTRY
K102674 · Ventlab Corp. · Jul 2011
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997