510(k) · Cleared
ClearedElectric Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Horigen Mother & Baby Products Co., Ltd. · HGX Pump, Breast, Powered
Cleared on May 6, 2022 as substantially equivalent to K181784 (Uzinmedicare Co., 2018) after a 266-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- May 6, 2022
- Review
- 266 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850705 (1985). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK850705 The White River Porta-Elec-Breast PumpNatural Technologies, Inc. · 1985
- 5 generations backK971543 Luxmatic 12-15 Isc Portable Electric Breast PumpKaweco GmbH · 1997
- 4 generations backK012275 PJ.S Comfort Portable Electric Breast PumpLimerick, Inc. · 2002
- 3 generations backK051926 Limerick PJ'S Comfort JR Portable Electric Breast PumpLimerick, Inc. · 2005
- 2 generations backK150476 Spectra S1Plus and Spectra S2 PlusUzinmedicare Co. · 2016
- 1 generation backK181784 Spectra S3 PlusUzinmedicare Co. · 2018
- This deviceK212564 Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850705 | The White River Porta-Elec-Breast Pump | Natural Technologies, Inc. | 1985 | — |
| −5 | K971543 | Luxmatic 12-15 Isc Portable Electric Breast Pump | Kaweco GmbH | 1997 | — |
| −4 | K012275 | PJ.S Comfort Portable Electric Breast Pump | Limerick, Inc. | 2002 | — |
| −3 | K051926 | Limerick PJ'S Comfort JR Portable Electric Breast Pump | Limerick, Inc. | 2005 | — |
| −2 | K150476 | Spectra S1Plus and Spectra S2 Plus | Uzinmedicare Co. | 2016 | — |
| −1 | K181784 | Spectra S3 Plus | Uzinmedicare Co. | 2018 | — |
| 0 (this device) | K212564 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 |
|---|---|---|---|
| * | K181784 | Spectra S3 PlusSummary page 4…y Class: Class II 5. Predicate Device Information Device Name: Spectra 3 Plus Breast Pump 510(k) Number: K181784 Manufacturer: Uzinmedicare Co. The predicate device has not been subject to a design-related recall.… | 2018 |
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 37 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K181784.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 is intended to be used by lactating women to express and collect milk from their breasts, to alleviate engorgement of the breasts, maintain the ability of lactation, and provide mother’s milk for future feedings when separation of mother and baby occurs. This electric breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212564: Electric Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212564
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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