KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)— 510(k) K253001
Substantially EquivalentHunan Ruijiong Biotech Co., Ltd.
FDA 510(k) clearance K253001 for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5), Substantially Equivalent on 2026-06-16. Applicant: Hunan Ruijiong Biotech Co., Ltd.. Device class: 2.
Summary
Hunan Ruijiong Biotech's KT Airway Clearance Device II comes in two models, KT-3 and KT-5. It's filed under NHJ, intermittent positive pressure breathing devices, and the record doesn't say how the models differ.
Class II, 21 CFR 868.5905. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Ruijiong filed from Xiangtan, China. Review took 270 calendar days (September 19, 2025 to June 16, 2026).
Clearance details
- Applicant
- Hunan Ruijiong Biotech Co., Ltd.
- Product code
- Product code NHJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiangtan, CN
Recent devices under product code NHJ
view allAdverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.