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FDA 510(k)

Electric Breast Pump (HL-3058 II Pro)

K-Number: K254125 · 2026-05-13

ApplicantFimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Decision Date2026-05-13
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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