# K091591: Flexicare Medical Endotracheal Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical, Ltd.
- Decided: Jun 17, 2009 after 15 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951696 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951696: Endotracheal Tube, Unomedical Sdn Bhd (1995) Summary page 1.

## Recalls of this device
- Sep 22, 2020 · Class I · Z-0497-2021: When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.

## Indications for use
The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.

Source page: https://510kreport.com/device/K091591
Methodology: https://510kreport.com/methodology