KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
FDA 510(k) clearance K253001 · decided 2026-06-16
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-19
- Decision date
- 2026-06-16
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- NHJ
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Xiangtan, CN
- Third-party review
- No
- Expedited review
- No
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| PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (K140598) | Dima Italia Srl | 2014-10-16 |
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Recalls involving this device
No recalls on record reference this clearance.