FDA 510(k)

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

Номер K: K253001 · 2026-06-16

ЗаявительHunan Ruijiong Biotech Co., Ltd.

Дата решения2026-06-16

Код продуктаNHJ

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NHJ)

K260604BiWaze Clear SystemAbmrc, LLC K242438ClearoBreas Medical AB K231728BiWaze Clear SystemAbmrc, LLC K213564BiWaze Clear SystemAbmrc, LLC K200988Maximus SystemHill-Rom Services Pte, Ltd.K191912BiWaze CoughAbmrc, LLC

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.