# K253001: KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Ruijiong Biotech Co., Ltd.
- Decided: Jun 16, 2026 after 270 days
- Product code: NHJ (Device, Positive Pressure Breathing, Intermittent)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K884098 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140598: Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc, Dima Italia Srl (2014) Summary page 5.

## Indications for use
The KT Airway Clearance Device II is designed for the use on patients unable to cough or clear secretions effectively by applying a positive pressure to the airway, then rapidly shifting to a negative pressure, or providing high frequency oscillatory vibrations. The device may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting. For use on adult or pediatric patients 3 years of age and older who have difficulty with secretion clearance and/or inability to cough.

Source page: https://510kreport.com/device/K253001
Methodology: https://510kreport.com/methodology