# K100546: Parker Flex- Tip Oral/Nasa Intubation Tube

- Pathway: 510(k) (Traditional)
- Applicant: Parkermedicalinc
- Decided: Jun 3, 2010 after 98 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 K822082 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984528: Parker Flex-Tip Tracheal Tube, Parker Medical Assoc. (1999) Summary page 1.

## Indications for use
Tracheal tube designed for oral and nasal intubation and indicated for airway management.

Source page: https://510kreport.com/device/K100546
Methodology: https://510kreport.com/methodology