Cleared Traditional

Pilling Tracheostomy Tubes

K233713 · Teleflex Medical · Anesthesiology
Mar 2024
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K233713 is an FDA 510(k) clearance for the Pilling Tracheostomy Tubes, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on March 22, 2024, 123 days after receiving the submission on November 20, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K233713 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2023
Decision Date March 22, 2024
Days to Decision 123 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTO — Tube, Tracheostomy (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

Similar Devices — BTO Tube, Tracheostomy (w/wo Connector)

All 127
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
K242921 · Vitaltec Corporation · Jun 2025
Venner PneuX? TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX? TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX? TT (Tracheostomy Tube) Size 9.0 mm
K192511 · Venner Medical (Singapore) Pte, Ltd. · Jul 2020
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384 · Smiths Medical Ads, Inc. · Apr 2018
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
K120079 · Primed Halberstadt Medizintechnik GmbH · May 2012
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K101721 · Regulatory and Marketing Services, Inc. · Mar 2011
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE
K100950 · Venner Medical (Singapore) Pte, Ltd. · Jul 2010