Cleared Traditional

Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula

K210833 · Smiths Medical Asd, Inc. · Anesthesiology
Nov 2021
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K210833 is an FDA 510(k) clearance for the Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 26, 2021, 252 days after receiving the submission on March 19, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K210833 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2021
Decision Date November 26, 2021
Days to Decision 252 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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