# K161813: Frova Intubating Introducer

- Pathway: 510(k) (Traditional)
- Applicant: William Cook Europe Aps
- Decided: May 19, 2017 after 322 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 K862347 (1986). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862347: Endotracheal Tube, Accessory, Sheridan Catheter Corp. (1986) Summary page 4.

## Most influential descendants
- K251499: Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (2025), 0 descendants of its own
- K171917: Frova Intubating Introducer (2018), 0 descendants of its own

## Indications for use
The Frova Intubating Introducer is intended to facilitate endotracheal intubation in patients where the visualization of the glottis in inadequate. The 14 French catheter has been designed for placement of a single lumen endotracheal tube whose inner diameter is 6 mm or larger.

Source page: https://510kreport.com/device/K161813
Methodology: https://510kreport.com/methodology