# K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Ltd.
- Decided: Aug 27, 2003 after 203 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903730 (1990). 6 ancestors in all.
8 later devices descend from it; 4 cite it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912124: Tracheostomy Tube and Cuff, Concord/Portex (1991) Summary page 1.
- K811033: Shiley Low Pressure Thin-Cuffed Trach, Shiley, Inc. (1981) Summary page 1.
- K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, Sims Portex, Inc. (1998) Summary page 1.

## Most influential descendants
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), 5 descendants of its own
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), 2 descendants of its own
- K180034: Weinmann Tracheostomy Exchange Set (2018), 1 descendant of its own
- K193133: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (2019), 0 descendants of its own
- K173912: BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (2018), 0 descendants of its own

## Recalls of this device
- Feb 11, 2019 · Class II · Z-1732-2019: Packaged with an incorrect size inner cannula.
- Mar 7, 2006 · Not classified · Z-0714-06: Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

## Indications for use
Portex Blue Line Ultra Tracheostomy Tube is indicated for airway maintenance of Tracheostomised patients

Source page: https://510kreport.com/device/K030381
Methodology: https://510kreport.com/methodology