# K192324: Sheridan Spiral-Flex Endotracheal Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Dec 6, 2019 after 101 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 K844296 (1984). 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)
- K844296: Tracheal Tube, Reinforced, Cuffed, Sheridan Catheter Corp. (1984) Summary page 4.
- K860105: Spiral-Flex, Sheridan Catheter Corp. (1986) Summary page 4.

## Indications for use
Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management.

Source page: https://510kreport.com/device/K192324
Methodology: https://510kreport.com/methodology