FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
K Number: K253001
·
Decision Jun 16, 2026
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
24
Applicant Total
1
Review Days
270
Basic Information
- Device Name
- KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
- K Number
- K253001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hunan Ruijiong Biotech Co., Ltd.
- Date Received
- September 19, 2025
- Decision Date
- June 16, 2026
- Product Code
- NHJ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NHJ | Device, Positive Pressure Breathing, Intermittent | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHJ), ordered by most recent decision date.
Clearo
FDA 510(k)
FDA Class 2
·Anesthesiology
BiWaze Clear System
FDA 510(k)
FDA Class 2
·Anesthesiology
BiWaze Clear System
FDA 510(k)
FDA Class 2
·Anesthesiology
Maximus System
FDA 510(k)
FDA Class 2
·Anesthesiology
BiWaze Cough
FDA 510(k)
FDA Class 2
·Anesthesiology
Maximus System
FDA 510(k)
FDA Class 2
·Anesthesiology