# K081086: Portex Blue Line Sacett Suction Above the Cuff Tracheal Tube, Size 6.0 and 6.5, 7.0 and 7.5, 8.0 and 8.5, 9.0

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Aug 13, 2008 after 119 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903730 (1990). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965132: HI-LO Evac and Evac II Endotracheal Tubes, Mallinckrodt Medical (1997) Summary page 1.
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube, Portex, Ltd. (2003) Summary page 1.
- (no number) Portex Tracheal Tube: named in the summary without a submission number

## Most influential descendants
- K091761: Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port (2009), 2 descendants of its own
- K141939: Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with Stylet (2014), 1 descendant of its own
- K190274: Endotracheal Tube (2019), 0 descendants of its own

## Indications for use
Portex® Blue Line® SACETT™ is intended for oral intubation only for airway management of patients anticipated to require prolonged mechanical ventilation in critical care units. The product may be inserted in the emergency room or pre-hospital to avoid the need for reintubation, SACETT™'s dorsal suction lumen allows drainage by continuous or intermittent suctioning of contaminated mucous and subglottis secretion that accumulate above the cuff.

Source page: https://510kreport.com/device/K081086
Methodology: https://510kreport.com/methodology