Cleared Traditional

K170720 - Portex Blue Line Ultra Paediatric Trach...

K170720 is the FDA 510(k) clearance for Portex Blue Line Ultra Paediatric Trach... by Smiths Medical Asd, Inc.. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K170720 · Smiths Medical Asd, Inc. · Anesthesiology device
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Dec 2017
Decision
273d
Days
Class 2
Risk

K170720 is an FDA 510(k) clearance for the Portex Blue Line Ultra Paediatric Tracheosomy Tube. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 7, 2017 after a review of 273 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 Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K170720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2017
Decision Date December 07, 2017
Days to Decision 273 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
133d slower than avg
Panel avg: 140d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K170720.
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
K173912 · Smiths Medical Asd, Inc. · May 2018
Weinmann Tracheostomy Exchange Set
K180034 · Cook Incorporated · May 2018
TRACOE silcosoft Tracheostomy Tube
K172720 · Tracoe Medical GmbH · Apr 2018
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
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
K142298 · Covidien · Feb 2015