# K041917: Plasiatek Actuator

- Pathway: 510(k) (Traditional)
- Applicant: Plasiatek, LLC
- Decided: Jan 7, 2005 after 175 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 K000045 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000045: Positube, Paraproducts, Inc. (2000) Summary page 1.

## Indications for use
The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using Doppler ultrasound imaging.

Source page: https://510kreport.com/device/K041917
Methodology: https://510kreport.com/methodology