K253001
- 510(k) number
- K253001
- Device name
- KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
- Applicant
- Hunan Ruijiong Biotech Co., Ltd. CN
- Product code
- NHJ — Device, Positive Pressure Breathing, Intermittent
- Decision date
- 2026-06-16
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K253001.pdf
Official FDA record: K253001
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.