# K243579: AeroJet Ventilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pipeline Medical Products, LLC
- Decided: Aug 13, 2025 after 267 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 K922880 (1993). 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)
- K922880: Xomed Treace Jet Ventilation Tube, Xomed-Treace, Inc. (1993) Summary page 5.

## Indications for use
The Aero Jet Ventilation Catheter is indicated to be used as a device for ventilating the patient by the administration of oxygen and air, a technique referred to as jet ventilation.

Source page: https://510kreport.com/device/K243579
Methodology: https://510kreport.com/methodology