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FDA 510(k)

Electric Breast Pump (HL-3058, F5112)

K-Number: K252629 · 2025-10-27

ApplicantFimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
Decision Date2025-10-27
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Electric Breast Pump (HL-3058, F5112) is a medical device manufactured by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. It received FDA 510(k) clearance on 2025-10-27 under approval number K252629. 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, F5112)?

Electric Breast Pump (HL-3058, F5112) is a medical device that received FDA 510(k) clearance on 2025-10-27. It is manufactured by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. The 510(k) number is K252629.

When was Electric Breast Pump (HL-3058, F5112) approved by the FDA?

Electric Breast Pump (HL-3058, F5112) received FDA 510(k) clearance on 2025-10-27, under approval number K252629.

What company makes Electric Breast Pump (HL-3058, F5112)?

Electric Breast Pump (HL-3058, F5112) is manufactured by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd..

What is the FDA product code for Electric Breast Pump (HL-3058, F5112)?

The FDA product code for Electric Breast Pump (HL-3058, F5112) is HGX.

Related Clinical Trials

NCT05746325 Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer RECRUITING

Other Devices by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

K240218Electric Breast Pump (F5055) K252630Electric Breast Pump (HL-3060, F5113) K254125Electric Breast Pump (HL-3058 II Pro)

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

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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