510(k) · Cleared
ClearedElectric Breast Pump (HL-3058 II Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · HGX Pump, Breast, Powered
Cleared on May 13, 2026 as substantially equivalent to K252629 (Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., 2025) after a 145-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- May 13, 2026
- Review
- 145 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K801862 (1980). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 7 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 6 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 5 generations backK092783 DEBPEnko, Ltd. · 2009
- 4 generations backK162415 Spectra 9PlusUzinmedicare Company · 2017
- 3 generations backK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
- 2 generations backK240218 Electric Breast Pump (F5055)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2024
- 1 generation backK252629 Electric Breast Pump (HL-3058, F5112)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2025
- This deviceK254125 Electric Breast Pump (HL-3058 II Pro)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −7 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −6 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −5 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −4 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| −3 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
| −2 | K240218 | Electric Breast Pump (F5055) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2024 | — |
| −1 | K252629 | Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025 | — |
| 0 (this device) | K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HGX device
- #1 K212180 Wearable Breast Pump (Model S12)score 34.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K252629 | Electric Breast Pump (HL-3058, F5112)Summary page 5…redicate Device 510(k) Number Fimilla (Shanghai) Electric Breast Pump (HL- Maternity & Baby Articles 3058, F5112) K252629 Co., Ltd The predicate device has not been subject to a design-related recall. IV. Device Description The Ele… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 46 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 12 ancestors have a recall of any class.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HGX
34so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HGX
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGX
69in 2025
MAUDE reports naming product code HGX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 4 | 121 | 0 | 0 |
| 2010 | 7 | 103 | 5 | 88 |
| 2011 | 2 | — | 1 | 240 |
| 2012 | 6 | 180 | 0 | 685 |
| 2013 | 4 | 131 | 0 | 837 |
| 2014 | 3 | 120 | 0 | 1,036 |
| 2015 | 9 | 141 | 0 | 496 |
| 2016 | 7 | 121 | 0 | 373 |
| 2017 | 8 | 159 | 1 | 437 |
| 2018 | 6 | 136 | 0 | 291 |
| 2019 | 7 | 158 | 0 | 168 |
| 2020 | 9 | 128 | 0 | 168 |
| 2021 | 12 | 240 | 0 | 119 |
| 2022 | 15 | 190 | 0 | 154 |
| 2023 | 15 | 167 | 0 | 200 |
| 2024 | 19 | 168 | 0 | 118 |
| 2025 | 26 | 122 | 0 | 69 |
| 2026 | 34 | 142 | 0 | — |
What is it indicated for?
The Electric Breast Pump (Model: HL-3058 II Pro) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254125: Electric Breast Pump (HL-3058 II Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254125
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026