510(k) · Cleared
ClearedWearable Breast Pump (Model S1DW)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen TPH Technology Co., Ltd. · HGX Pump, Breast, Powered
Cleared on Jan 4, 2023 as substantially equivalent to K211755 (Zhejiang Carebao Co., Ltd., 2021) after a 177-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Jan 4, 2023
- Review
- 177 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 backK211755 Electric Breast PumpZhejiang Carebao Co., Ltd. · 2021
- This deviceK222045 Wearable Breast Pump (Model S1DW)Shenzhen TPH Technology Co., Ltd. · 2023
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 | K211755 | Electric Breast Pump | Zhejiang Carebao Co., Ltd. | 2021 | — |
| 0 (this device) | K222045 | Wearable Breast Pump (Model S1DW) | Shenzhen TPH Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K211755 | Electric Breast PumpSummary page 4…lass: Class II 5. Predicate Device Information Device Name: Electric Breast Pump 510(k) Number: K211755 Manufacturer: Zhejiang Carebao Co., Ltd. The predicate device has not been subject to a design-rel… | 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 43 years and passes through 7 companies; a new generation was cleared every 4.2 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. 2023, 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 Breast Pump (Model S1DW) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222045: Wearable Breast Pump (Model S1DW).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222045
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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