510(k) · Cleared
ClearedWearable Breast Pump (Model S18)
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 Jul 14, 2023 as substantially equivalent to K212180 (Shenzhen TPH Technology Co., Ltd., 2022) after a 199-day review. Its family tree reaches back 9 generations to 1980. 1 later device descends from it.
- Decided
- Jul 14, 2023
- Review
- 199 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K801862 (1980). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 5 generations between
- 3 generations backK161266 Athena Breast PumpExploramed Nc7, Inc. · 2016
- 2 generations backK191577 Willow Wearable Breast Pump 2.0Exploramed Nc7, Inc. · 2019
- 1 generation backK212180 Wearable Breast Pump (Model S12)Shenzhen TPH Technology Co., Ltd. · 2022
- This deviceK223886 Wearable Breast Pump (Model S18)Shenzhen TPH Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250152 eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable…Shenzhen TPH Technology Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 8 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 7 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 6 generations backK092783 DEBPEnko, Ltd. · 2009
- 5 generations backK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- 4 generations backK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- 3 generations backK161266 Athena Breast PumpExploramed Nc7, Inc. · 2016
- 2 generations backK191577 Willow Wearable Breast Pump 2.0Exploramed Nc7, Inc. · 2019
- 1 generation backK212180 Wearable Breast Pump (Model S12)Shenzhen TPH Technology Co., Ltd. · 2022
- This deviceK223886 Wearable Breast Pump (Model S18)Shenzhen TPH Technology Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K250152eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03)…Shenzhen TPH Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −8 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −7 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −6 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −5 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| −4 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| −3 | K161266 | Athena Breast Pump | Exploramed Nc7, Inc. | 2016 | — |
| −2 | K191577 | Willow Wearable Breast Pump 2.0 | Exploramed Nc7, Inc. | 2019 | — |
| −1 | K212180 | Wearable Breast Pump (Model S12) | Shenzhen TPH Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K223886 | Wearable Breast Pump (Model S18) | Shenzhen TPH Technology Co., Ltd. | 2023 | — |
| +1 | K250152 | eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump… | 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 |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K212180 | Wearable Breast Pump (Model S12)Summary page 4…) Regulatory Class: Class II 4. Predicate Device Device Name: Wearable Breast Pump (Model S12) Information: 510(k) Number: K212180 Manufacturer: Shenzhen TPH Technology Co., Ltd. The predicate device has not been sub… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250152 | eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03)… | 2025 | 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 43 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K250152 (Shenzhen TPH Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K212180.
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 S18) 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/K223886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223886: Wearable Breast Pump (Model S18).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223886
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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