# K934465: Dic Tracheostomy Tube and Portex Blue Line

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: Jan 14, 1994 after 123 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K955564: Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile (1996), 5 descendants of its own
- K964056: Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy Kit Uncuffed Sterile (1997), 4 descendants of its own
- K972546: Rusch Single Use Crystal Tracheostomy Tube Set (1998), 2 descendants of its own
- K122235: Rusch Tracflex Plus Tracheostomy Tube Set (2013), 1 descendant of its own
- K031057: Per-Fit Percutaneous Dilational Tracheostomy Kit (2003), 1 descendant of its own

## Recalls of this device
- Sep 9, 2004 · Not classified · Z-0229-05: Sterility of the device is compromised due to packaging defects
- Sep 9, 2004 · Not classified · Z-0228-05: Sterility of the device is compromised due to packaging defects

Source page: https://510kreport.com/device/K934465
Methodology: https://510kreport.com/methodology