Cleared Special

K122531 - SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS

K122531 is an FDA 510(k) clearance for SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Special 510(k) pathway after a 50-day FDA review.

K122531 · Covidien · Anesthesiology device
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Oct 2012
Decision
50d
Days
Class 2
Risk

K122531 is an FDA 510(k) clearance for the SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUB.... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on October 9, 2012 after a review of 50 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 Covidien devices

FDA 510(k) Submission Details - K122531

510(k) Number K122531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2012
Decision Date October 09, 2012
Days to Decision 50 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
90d faster than avg
Panel avg: 140d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

JOH Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K122531.
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
K133173 · Teleflexmedical, Inc. · May 2014
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
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
K093469 · Cook, Inc. · Jan 2010
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