# K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Concord/Portex
- Decided: Sep 25, 1990 after 40 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
No predicates in its family tree.
38 later devices descend from it; 4 cite it directly.
4 of 39 devices in its family (counting itself) have 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
- K960429: Per-Fit Percutaneous Tracheostomy Kit W/Portex       Tracheostmy Tube & Disp. Inner Cannula (1996), 32 descendants of its own
- K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula (1998), 31 descendants of its own
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), 21 descendants of its own
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula (2003), 8 descendants of its own

Source page: https://510kreport.com/device/K903730
Methodology: https://510kreport.com/methodology