Cleared Special

K113644 - PILOT TUBE REPAIR KIT

K113644 is the FDA 510(k) clearance for PILOT TUBE REPAIR KIT by Instrumentation Industries, Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

Device Classification

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 17
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K113644.
AG 100s
K180991 · Hospitech Respiration , Ltd. · Oct 2018
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
CUFF PILOT, SURE SEAL
K142103 · Teleflexmedical, Inc. · May 2015
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997
RUSCH ENDOTEST CUFF PRESSURE MONITOR
K951046 · Rusch Intl. · Apr 1995
BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
K884638 · Instrumentation Industries, Inc. · Nov 1988