Cleared Traditional

K030570 - BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE

K030570 is an FDA 510(k) clearance for BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY..., manufactured by Portex , Ltd.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K030570 · Portex , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
205d
Days
Class 2
Risk

K030570 is an FDA 510(k) clearance for the BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Portex , Ltd. (Hyth, Kent, GB). The FDA issued a Cleared decision on September 17, 2003 after a review of 205 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.

FDA 510(k) Submission Details - K030570

510(k) Number K030570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2003
Decision Date September 17, 2003
Days to Decision 205 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
65d slower than avg
Panel avg: 140d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 123
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K030570.
CS MEDICAL ADULT TTCF CATHETER
K050379 · Cs Medical, Inc. · Jul 2005
WELL LEAD TRACHEOSTOMY TUBE
K042684 · Well Lead Medical Instruments · Feb 2005
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
K031553 · Arcadia Medical Corporation · Nov 2003
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
K030381 · Portex , Ltd. · Aug 2003
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
K021764 · Rusch Intl. · Jul 2002
CRICOTHYROTOMY TUBE
K983000 · Polamedco, Inc. · Oct 1999
K030570 · BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
Download PDF FDA Summary Portex , Ltd.