# K170720: Portex Blue Line Ultra Paediatric Tracheosomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Dec 7, 2017 after 273 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- 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 K081440 (2008). 5 ancestors in all.
No later device cites it as a predicate yet.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912469: Bivona Wire Reinforced Pediatric Tracheostomy Tube, Bivona Medical Technologies (1991) Summary page 5.
- K122531: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T, Covidien (2012) Summary page 5.

## Indications for use
Portex® Blue Line Ultra® Paediatric Tracheostomy Tubes are indicated for airway maintenance of tracheostomised patients.

Source page: https://510kreport.com/device/K170720
Methodology: https://510kreport.com/methodology