# K862347: Endotracheal Tube, Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Sheridan Catheter Corp.
- Decided: Jul 11, 1986 after 21 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K161813: Frova Intubating Introducer (2017), 2 descendants of its own
- 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
- K162729: Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip (2017), 0 descendants of its own

## Recalls of this device
- Sep 27, 2006 · Not classified · Z-0129-2007: Biological indicator failed. Investigation eliminated all equipment and product related factors.

Source page: https://510kreport.com/device/K862347
Methodology: https://510kreport.com/methodology