Electric Breast Pump (HL-3058 II Pro)— 510(k) K254125
Substantially EquivalentFimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
FDA 510(k) clearance K254125 for Electric Breast Pump (HL-3058 II Pro), Substantially Equivalent on 2026-05-13. Applicant: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. Device class: 2.
Summary
Fimilla (Shanghai) Maternity & Baby Articles filed the Electric Breast Pump (HL-3058 II Pro) under HGX, powered breast pumps. Apart from the model number, the name is generic.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel. It was a Traditional 510(k).
Fimilla filed from Shanghai, China. Review took 145 calendar days (December 19, 2025 to May 13, 2026).
Clearance details
- Applicant
- Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
- Product code
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code HGX
view all- K262125 — Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
- K261782 — MODO DUO Electric Pump (B11621, B11673)
- K254203 — Wearable Breast Pump (Model S36)
- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
More clearances from Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.