FDA 510(k)

Electric Breast Pump (HL-3058 II Pro)

Número K: K254125 · 2026-05-13

RequerenteFimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

Data da decisão2026-05-13

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric Breast Pump (HL-3058 II Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K254125. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Electric Breast Pump (HL-3058 II Pro)?

Electric Breast Pump (HL-3058 II Pro) is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. The 510(k) number is K254125.

When did Electric Breast Pump (HL-3058 II Pro) receive FDA 510(k) clearance?

Electric Breast Pump (HL-3058 II Pro) received FDA 510(k) clearance on 2026-05-13, under 510(k) number K254125.

Who is the listed applicant for Electric Breast Pump (HL-3058 II Pro)?

The FDA 510(k) record lists Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Breast Pump (HL-3058 II Pro)?

The FDA product code for Electric Breast Pump (HL-3058 II Pro) is HGX.

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Outros registros que listam Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. como candidato(a)

K252629Electric Breast Pump (HL-3058, F5112)K252630Electric Breast Pump (HL-3060, F5113)K240218Electric Breast Pump (F5055)

Dispositivos Relacionados (Código: HGX)

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.

Fonte oficial

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