# K922749: Low Profile Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Concord/Portex
- Decided: Sep 2, 1992 after 86 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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
- Jun 18, 2003 · Not classified · Z-1039-03: Mislabeled:Tracheostomy tube was not fenestrated as specified on the label

Source page: https://510kreport.com/device/K922749
Methodology: https://510kreport.com/methodology