# K031553: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Arcadia Medical Corporation
- Decided: Nov 18, 2003 after 183 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862267 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862267: Fome-Cuf and Aire Cuf Tracheostomy Tubes, Bivona Medical Technologies (1986) Summary page 1.
- K894614: Bivona Aire-Cuf Adjustable Tracheostomy Tube, Bivona Medical Technologies (1989) Summary page 1.
- K912469: Bivona Wire Reinforced Pediatric Tracheostomy Tube, Bivona Medical Technologies (1991) Summary page 1.

## Most influential descendants
- K100480: Rota-Trach Tracheostomy Tube Model Rota-Trach (2010), 0 descendants of its own

## Recalls of this device
- Apr 18, 2012 · Not classified · Z-1628-2012: A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
- May 8, 2011 · Not classified · Z-2657-2011: The product does not contain a punched hole above the cuff access port (a lumen that enables suctioning of secretions proximal to the inflated cuff) as intended by the devices design. This eliminates 

## Indications for use
Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.

Source page: https://510kreport.com/device/K031553
Methodology: https://510kreport.com/methodology