Cleared Traditional

PREFILLED WATER FOR IRRIGATION USP

K880316 · Automatic Liquid Packaging, Inc. · Anesthesiology
Feb 1988
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K880316 is an FDA 510(k) clearance for the PREFILLED WATER FOR IRRIGATION USP, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on February 29, 1988, 34 days after receiving the submission on January 26, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K880316 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1988
Decision Date February 29, 1988
Days to Decision 34 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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
Pilling Tracheostomy Tubes
K233713 · Teleflex Medical · Mar 2024
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