# K962175: Portex Adjustable Flange Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: Jan 17, 1997 after 226 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 3 cite it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PORTEX® Blue Line™ Tracheostomy Tube: named in the summary without a submission number
- (no number) BIVONA Hyperflex Tracheostomy Tube Adjustable Neckflange: named in the summary without a submission number

## Most influential descendants
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits (2003), 10 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only (2004), 6 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own

## Recalls of this device
- Aug 14, 2017 · Class II · Z-3213-2017: Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized o

## Indications for use
The PORTEX® Adjustable Flange Tracheostomy Tube is indicated for airway management of tracheostomized patients where the ability to adjust the depth of insertion may be advantageous.

Source page: https://510kreport.com/device/K962175
Methodology: https://510kreport.com/methodology