Cleared Traditional

K031553 - SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

K031553 is an FDA 510(k) clearance for SILICONE FOAM CUFF TRACHEOSTOMY TUBES, manufactured by Arcadia Medical Corporation. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K031553 · Arcadia Medical Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
183d
Days
Class 2
Risk

K031553 is an FDA 510(k) clearance for the SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATR.... Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Arcadia Medical Corporation (Appollo Beach, US). The FDA issued a Cleared decision on November 18, 2003 after a review of 183 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 - K031553

510(k) Number K031553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2003
Decision Date November 18, 2003
Days to Decision 183 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
43d slower than avg
Panel avg: 140d · This submission: 183d
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 82
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K031553.
TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
K051587 · Tracoe Medical GmbH · Oct 2005
CS MEDICAL ADULT TTCF CATHETER
K050379 · Cs Medical, Inc. · Jul 2005
WELL LEAD TRACHEOSTOMY TUBE
K042684 · Well Lead Medical Instruments · Feb 2005
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
K030570 · Portex , Ltd. · Sep 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