PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA— 510(k) K030381

Clearance details

Applicant

Portex , Ltd.

Product code

Code BTO

Device class

Class 2

Regulation

21 CFR 868.5800

Advisory panel

Anesthesiology

Date received

2003-02-05

Decision date

2003-08-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

England Ct21 6db, GB

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• K233713 — Pilling Tracheostomy Tubes2024-03-22
• K192511 — 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 mm2020-07-22
• K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube2018-04-10

• K040014 — PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY2004-02-13
• K032112 — P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED)2004-01-26
• K033084 — WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER2003-12-19
• K032716 — PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)2003-11-28
• K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE2003-09-17

Death

14

Injury

328

Malfunction

1,851

Total

2,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1732-2019 — Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.Class II·Terminated·Smiths Medical ASD Inc.·20190211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030381.