510(k) K254125 ยท HGX Pump, Breast, Powered
Electric Breast Pump (HL-3058 II Pro)
| Applicant | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, May 13, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254125
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.