Clearance Summary
KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) received FDA 510(k) clearance under submission number K253001, sponsored by Hunan Ruijiong Biotech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-06-16.
- Submission: K253001
- Applicant / Sponsor: Hunan Ruijiong Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2026-06-16
Classification & Regulation
This clearance is catalogued under FDA product code NHJ and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.