# K233713: Pilling Tracheostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Mar 22, 2024 after 123 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
Longest line of descent: 4 generations back to K781729 (1978). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123699: Fahl Tracheostomy Tubes (Multiple), Andreas Fahl Medizintechnik-Vertrieb GmbH (2013) Summary page 5.

## Indications for use
Tracheostomy tubes are intended to provide tracheal access for airway management of tracheostomized patients.

Source page: https://510kreport.com/device/K233713
Methodology: https://510kreport.com/methodology