510(k) · Cleared
ClearedElectric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
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 Sep 11, 2020 as substantially equivalent to K182413 (Guangdong Horigen Mother & Baby Products Co., Ltd., 2019) after a 273-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Sep 11, 2020
- Review
- 273 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 backK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- 2 generations backK143585 Electric Breast PumpShantou Xinghe Electrical Apparatuses Co., Ltd. · 2015
- 1 generation backK182413 Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2019
- This deviceK193449 Electric Breast Pump (model KP033_01), Electric Double Breast Pump…Guangdong Horigen Mother & Baby Products Co., Ltd. · 2020
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 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| −2 | K143585 | Electric Breast Pump | Shantou Xinghe Electrical Apparatuses Co., Ltd. | 2015 | — |
| −1 | K182413 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2019 | — |
| 0 (this device) | K193449 | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model… | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2020 | — |
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 |
|---|---|---|---|
| * | K182413 | Electric Breast PumpSummary page 4…tion Name: Powered Breast Pump Product Code: HGX (Pump, Breast, Powered) Regulatory Class: II III. PREDICATE DEVICE The predicate device is the Electric Breast Pump (K182413). This predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Electric Breast Pump (m… | 2019 |
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 40 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 11 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. 2020, 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 KP033_01), Electric Double Breast Pump (model KP053 01) are intended to express and collect milk from the mother’s breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother’s milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053 01) are intended for a 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/K193449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193449: Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193449
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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