FDA 510(k)

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)

Número K: K253001 · 2026-06-16

RequerenteHunan Ruijiong Biotech Co., Ltd.

Data da decisão2026-06-16

Código do produtoNHJ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Ruijiong Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253001. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)?

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Hunan Ruijiong Biotech Co., Ltd.. The 510(k) number is K253001.

When did KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) receive FDA 510(k) clearance?

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253001.

Who is the listed applicant for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)?

The FDA 510(k) record lists Hunan Ruijiong Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)?

The FDA product code for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) is NHJ.

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