Cleared Traditional

K142298 - Shiley Neonatal

K142298 is an FDA 510(k) clearance for Shiley Neonatal, manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K142298 · Covidien · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
179d
Days
Class 2
Risk

K142298 is an FDA 510(k) clearance for the Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuar.... 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 February 13, 2015 after a review of 179 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Covidien devices

FDA 510(k) Submission Details - K142298

510(k) Number K142298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2014
Decision Date February 13, 2015
Days to Decision 179 days
Submission Type Traditional
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
39d slower than avg
Panel avg: 140d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K142298.
Portex Blue Line Ultra Paediatric Tracheosomy Tube
K170720 · Smiths Medical Asd, Inc. · Dec 2017
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
K150844 · Covidien · Jul 2015
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula
K142296 · Covidien · Feb 2015
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