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FDA 510(k)

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)

N.º K: K254254 · 2026-06-18

SolicitanteShenzhen Root Innovation Technology Co., Ltd.
Fecha de decisión2026-06-18
Código de productoHGX
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) 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 2026-06-18 under 510(k) number K254254. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)?

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K254254.

When did Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) receive FDA 510(k) clearance?

Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K254254.

Who is the listed applicant for Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)?

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 Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)?

The FDA product code for Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) is HGX.

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

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )K253629Momcozy Nasal Aspirator (BN007)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: HGX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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