510(k) · Cleared
ClearedElectric Breast Pump (F5055)
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 Oct 17, 2024 as substantially equivalent to K163136 (Ningbo Youhe Electrical Appliance Technology Co., Ltd., 2017) after a 265-day review. Its family tree reaches back 6 generations to 1980. 3 later devices descend from it.
- Decided
- Oct 17, 2024
- Review
- 265 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K801862 (1980). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 5 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 4 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 3 generations backK092783 DEBPEnko, Ltd. · 2009
- 2 generations backK162415 Spectra 9PlusUzinmedicare Company · 2017
- 1 generation backK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
- This deviceK240218 Electric Breast Pump (F5055)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK252629 Electric Breast Pump (HL-3058, F5112)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK254125 Electric Breast Pump (HL-3058 II Pro)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252630 Electric Breast Pump (HL-3060, F5113)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K252629Electric Breast Pump (HL-3058, F5112)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2025 · cites it directly1descendant
- K254125Electric Breast Pump (HL-3058 II Pro)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2026 · 2 generations on0descendants
- K252630Electric Breast Pump (HL-3060, F5113)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −5 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −4 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −3 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −2 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| −1 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
| 0 (this device) | 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 | — |
| +2 | K254125 | Electric Breast Pump (HL-3058 II Pro) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2026 | — |
| +1 | K252630 | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K163136 | Youha electric breast pumpSummary page 5…Product Code: HGX (Pump, Breast, Powered); Regulation Number: 21 CFR 884.5160; 5. Identification of Predicate Device Device510(K) Number: K163136 Product Name: Youha electric breast pump Models: YH-8004, YH-8016, YH-8006IV, YH-8015 The predicate devic… | 2017 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 44 years and passes through 6 companies; a new generation was cleared every 7.2 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K252629 (Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K163136.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 (F5059) 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/K240218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240218: Electric Breast Pump (F5055).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026