510(k) · Cleared
ClearedWearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cixi Ruihong Electric Appliance Co., Ltd. · HGX Pump, Breast, Powered
Cleared on Apr 3, 2026 as substantially equivalent to K201903 (Cixi Ruihong Electric Appliance Co., Ltd., 2021) after a 217-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Apr 3, 2026
- Review
- 217 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K801862 (1980). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 6 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 5 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 4 generations backK092783 DEBPEnko, Ltd. · 2009
- 3 generations backK162415 Spectra 9PlusUzinmedicare Company · 2017
- 2 generations backK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
- 1 generation backK201903 Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd. · 2021
- This deviceK252744 Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)Cixi Ruihong Electric Appliance Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −6 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −5 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −4 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −3 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| −2 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
| −1 | K201903 | Electric breast pump (Models: RH-228 and RH-338) | Cixi Ruihong Electric Appliance Co., Ltd. | 2021 | — |
| 0 (this device) | K252744 | Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance 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 |
|---|---|---|---|
| * | K201903 | Electric breast pump (Models: RH-228 and RH-338)Summary page 6…page 2 of 8 Electric breast pump (Models: RH-228 and Device Name RH-338) 510(k) Number K201903 The predicate device has not been subject to a design-related recall. 4. Device Description The Wearable Electric Breast Pump i… | 2021 |
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 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K201903.
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 Wearable Electric Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252744: Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252744
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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