# K060094: Arcadia Medical Silicone Wire Reinforced Endotracheal Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Arcadia Medical Corporation
- Decided: May 8, 2006 after 116 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792035 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792035: Fome-Cuf-Wire RE-Enforced, Aire-Cuf Wire, Bivona Medical Technologies (1979) Summary page 1.
- K830352: Reinforced Silicone Tracheal Tube, Portex, Inc. (1983) Summary page 1.
- K954750: Pediatric Wire Reinforced Silicone Endotracheal Tube, Unomedical Sdn Bhd (1995) Summary page 1.
- K954754: Wire Reinforced Silicone Endotracheal Tube, Unomedical Sdn Bhd (1995) Summary page 1.
- K991580: Ilm Endotracheal Tube, The Laryngeal Mask Co., Ltd. (2000) Summary page 1.

## Indications for use
Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).

Source page: https://510kreport.com/device/K060094
Methodology: https://510kreport.com/methodology