Cleared Special

K093469 - CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEO...

K093469 is the FDA 510(k) clearance for CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEO... by Cook, Inc.. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Special 510(k) pathway after a 63-day FDA review.

K093469 · Cook, Inc. · Anesthesiology device
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Jan 2010
Decision
63d
Days
Class 2
Risk

K093469 is an FDA 510(k) clearance for the CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MUL.... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on January 8, 2010 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 Cook, Inc. devices

Submission Details

510(k) Number K093469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2009
Decision Date January 08, 2010
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - JOH Tube Tracheostomy And Tube Cuff

All 57
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K093469.
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
K133597 · Cook, Inc. · Apr 2014
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
K122235 · Teleflexmedical, Inc. · Sep 2013
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
K122531 · Covidien · Oct 2012
BIVONA TRACHEOSTOMY TUBES
K083641 · Smiths Medical Asd, Inc. · Feb 2009
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
K081440 · Smiths Medical Asd, Inc. · Sep 2008
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · Cook, Inc. · Oct 2007