FDA 510(k)

Momcozy Nasal Aspirator (BN007)

N.º K: K253629 · 2026-05-26

SolicitanteShenzhen Root Innovation Technology Co., Ltd.

Fecha de decisión2026-05-26

Código de productoBTA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Momcozy Nasal Aspirator (BN007) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K253629. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Momcozy Nasal Aspirator (BN007)?

Momcozy Nasal Aspirator (BN007) is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K253629.

When did Momcozy Nasal Aspirator (BN007) receive FDA 510(k) clearance?

Momcozy Nasal Aspirator (BN007) received FDA 510(k) clearance on 2026-05-26, under 510(k) number K253629.

Who is the listed applicant for Momcozy Nasal Aspirator (BN007)?

The FDA 510(k) record lists Shenzhen Root Innovation Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Momcozy Nasal Aspirator (BN007)?

The FDA product code for Momcozy Nasal Aspirator (BN007) is BTA.

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Otros registros que enlistan a Shenzhen Root Innovation Technology Co., Ltd. como solicitante

K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)K254258Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)K253946Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: BTA)

K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)Shenzhen Desida Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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