# K171917: Frova Intubating Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Apr 23, 2018 after 300 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: 2 generations back to K862347 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161813: Frova Intubating Introducer, William Cook Europe Aps (2017) Summary page 4.

## Indications for use
To facilitate endotracheal intubation in adult and pediatric patients where visualization of the glottis is inadequate. The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age.

Source page: https://510kreport.com/device/K171917
Methodology: https://510kreport.com/methodology