510(k) · Cleared
ClearedWearable Breast Pump (Model S12)
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 Feb 11, 2022 as substantially equivalent to K191577 (Exploramed Nc7, Inc., 2019) after a 214-day review. Its family tree reaches back 8 generations to 1980. 25 later devices descend from it.
- Decided
- Feb 11, 2022
- Review
- 214 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K801862 (1980). 12 ancestors in all. 25 later devices descend from it, 10 citing it directly.
- Root · 8 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 7 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 6 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 5 generations backK092783 DEBPEnko, Ltd. · 2009
- 4 generations backK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- 3 generations backK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- 2 generations backK161266 Athena Breast PumpExploramed Nc7, Inc. · 2016
- 1 generation backK191577 Willow Wearable Breast Pump 2.0Exploramed Nc7, Inc. · 2019
- This deviceK212180 Wearable Breast Pump (Model S12)Shenzhen TPH Technology Co., Ltd. · 2022
- Descendant · cites it directly · 8 of its ownK242850 Wearable breast pump (model W8)Shenzhen TPH Technology Co., Ltd. · 2025
- Descendant · cites it directly · 2 of its ownK240536 Wearable Breast Pump (Model S32)Shenzhen TPH Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK252420 Wearable Breast Pump (Model W12)Shenzhen TPH Technology Co., Ltd. · 2026
- Descendant · cites it directly · 1 of its ownK250383 Wearable Breast Pump (Model W6)Shenzhen TPH Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK250843 Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)Shenzhen TPH Technology Co., Ltd. · 2025
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K242850Wearable breast pump (model W8)Shenzhen TPH Technology Co., Ltd. · 2025 · cites it directly8descendants
- K240536Wearable Breast Pump (Model S32)Shenzhen TPH Technology Co., Ltd. · 2024 · cites it directly2descendants
- K252420Wearable Breast Pump (Model W12)Shenzhen TPH Technology Co., Ltd. · 2026 · 2 generations on1descendant
- K250383Wearable Breast Pump (Model W6)Shenzhen TPH Technology Co., Ltd. · 2025 · cites it directly1descendant
- K250843Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)Shenzhen TPH Technology Co., Ltd. · 2025 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −7 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −6 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −5 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −4 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| −3 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| −2 | K161266 | Athena Breast Pump | Exploramed Nc7, Inc. | 2016 | — |
| −1 | K191577 | Willow Wearable Breast Pump 2.0 | Exploramed Nc7, Inc. | 2019 | — |
| 0 (this device) | K212180 | Wearable Breast Pump (Model S12) | Shenzhen TPH Technology Co., Ltd. | 2022 | — |
| +1 | K242850 | Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. | 2025 | — |
| +1 | K240536 | Wearable Breast Pump (Model S32) | Shenzhen TPH Technology Co., Ltd. | 2024 | — |
| +2 | K252420 | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | 2026 | — |
| +1 | K250383 | Wearable Breast Pump (Model W6) | Shenzhen TPH Technology Co., Ltd. | 2025 | — |
| +1 | K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | Shenzhen TPH Technology 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 9 | 0 |
| 2026 | 10 | 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 K242850 Wearable breast pump (model W8)score 32.3 · 9 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 |
|---|---|---|---|
| * | K191577 | Willow Wearable Breast Pump 2.0Summary page 4…ass: Class II 5. Predicate Device Information Device Name: Willow Wearable Breast Pump 510(k) Number: K191577 Manufacturer: Exploramed NC7, Inc. The predicate device has not been subject to a design-related rec… | 2019 |
What descends from it? (25)
See all 2510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242850 | Wearable breast pump (model W8) | 2025 | 8 |
| K240536 | Wearable Breast Pump (Model S32) | 2024 | 2 |
| K250383 | Wearable Breast Pump (Model W6) | 2025 | 1 |
| K250843 | Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | 2025 | 1 |
| K250368 | Wearable Breast Pump (Model S21) | 2025 | 1 |
| K230102 | Smart double sides wearable breast pump, Electric bilateral breast pump | 2023 | 1 |
| K223886 | Wearable Breast Pump (Model S18) | 2023 | 1 |
| K250365 | Motif Aura Glow breast pump (Model Motif Aura Glow) | 2025 | 0 |
| K231969 | BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) | 2024 | 0 |
| K220596 | Wearable Breast Pump (Model S9) | 2022 | 0 |
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 42 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K242850 (Shenzhen TPH Technology Co., Ltd., 2025) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K191577.
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 Wearable Breast Pump (Model S12) 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212180: Wearable Breast Pump (Model S12).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212180
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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