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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 a medical device manufactured by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. It received FDA 510(k) clearance on 2026-05-13 under approval 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. It is manufactured by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. The 510(k) number is K254125.

When was Electric Breast Pump (HL-3058 II Pro) approved by the FDA?

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

What company makes Electric Breast Pump (HL-3058 II Pro)?

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

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.

Related Devices (Code: HGX)

K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)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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