# K030570: Blue Line Ultra Suctionaid Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Ltd.
- Decided: Sep 17, 2003 after 205 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903730 (1990). 9 ancestors in all.
21 later devices descend from it; 3 cite it directly.
2 of 31 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.
- K965132: HI-LO Evac and Evac II Endotracheal Tubes, Mallinckrodt Medical (1997) Summary page 1.
- K923559: Steri-Cath Mdi, Concord/Portex (1993) Summary page 1.
- K912967: Bivona Aire-Cuf Tracheostomy Tube W/Talk Attach., Bivona Medical Technologies (1991) Summary page 1.

## Most influential descendants
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own
- K173384: BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (2018), 4 descendants of its own
- K130304: Lma Family of Airways (2014), 4 descendants of its own

## Indications for use
The Portex Blue Line Ultra Suctionaid Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid allows aspiration of mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.

Source page: https://510kreport.com/device/K030570
Methodology: https://510kreport.com/methodology