510(k) K254125
K254125 is an FDA 510(k) premarket notification submitted by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. for the device "Electric Breast Pump (HL-3058 II Pro)". The FDA issued a decision of Substantially Equivalent on May 13, 2026. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2026
- Date Received
- December 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Breast, Powered
- Device Class
- Class II
- Regulation Number
- 884.5160
- Review Panel
- OB
- Submission Type