# K120079: Primed Tracheostomy Tubes (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Primed Halberstadt Medizintechnik GmbH
- Decided: May 24, 2012 after 135 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: 2 generations back to K781729 (1978). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051587: Tracoe-Vario Tracheostomy Tubes (Various) Reference Models:  450, 455, 460, 465, 470, Tracoe Medical GmbH (2005) Summary page 2.
- K043160: Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist I-650-T/to and 650-S/SO, Tracoe Medical GmbH (2005) Summary page 2.
- K961449: Tracheostomy Tubes Tracoe-Flex, Tracoe Medical GmbH (1996) Summary page 2.
- K781729: Tracheotomy Tubes, Tracoe Medical GmbH (1978) Summary page 2.
- K083641: Bivona Tracheostomy Tubes, Smiths Medical Asd, Inc. (2009) Summary page 2.
- K013321: Silicone Tracheal T-Tubes, Technical Products, Inc. (2002) Summary page 2.
- K063125: Filterflo Hepa; Thermoflo Hepa (Filter / Hme), Arc Medical, Inc. (2007) Summary page 2.

## Most influential descendants
- K123699: Fahl Tracheostomy Tubes (Multiple) (2013), 1 descendant of its own
- K233713: Pilling Tracheostomy Tubes (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K120079
Methodology: https://510kreport.com/methodology