510(k) · Cleared
ClearedWillow Wearable Breast Pump 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exploramed Nc7, Inc. · HGX Pump, Breast, Powered
Cleared on Sep 6, 2019 as substantially equivalent to K161266 (Exploramed Nc7, Inc., 2016) after an 84-day review. Its family tree reaches back 7 generations to 1980. 27 later devices descend from it.
- Decided
- Sep 6, 2019
- Review
- 84 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. 27 later devices descend from it, 2 citing it directly.
- 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 backK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- 1 generation backK161266 Athena Breast PumpExploramed Nc7, Inc. · 2016
- This deviceK191577 Willow Wearable Breast Pump 2.0Exploramed Nc7, Inc. · 2019
- Descendant · cites it directly · 25 of its ownK212180 Wearable Breast Pump (Model S12)Shenzhen TPH Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 8 of its ownK242850 Wearable breast pump (model W8)Shenzhen TPH Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 2 of its ownK240536 Wearable Breast Pump (Model S32)Shenzhen TPH Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK252420 Wearable Breast Pump (Model W12)Shenzhen TPH Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK250383 Wearable Breast Pump (Model W6)Shenzhen TPH Technology Co., Ltd. · 2025
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K212180Wearable Breast Pump (Model S12)Shenzhen TPH Technology Co., Ltd. · 2022 · cites it directly25descendants
- K242850Wearable breast pump (model W8)Shenzhen TPH Technology Co., Ltd. · 2025 · 2 generations on8descendants
- K240536Wearable Breast Pump (Model S32)Shenzhen TPH Technology Co., Ltd. · 2024 · 2 generations on2descendants
- K252420Wearable Breast Pump (Model W12)Shenzhen TPH Technology Co., Ltd. · 2026 · 3 generations on1descendant
- K250383Wearable Breast Pump (Model W6)Shenzhen TPH Technology Co., Ltd. · 2025 · 2 generations on1descendant
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 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| −1 | K161266 | Athena Breast Pump | Exploramed Nc7, Inc. | 2016 | — |
| 0 (this device) | K191577 | Willow Wearable Breast Pump 2.0 | Exploramed Nc7, Inc. | 2019 | — |
| +1 | K212180 | Wearable Breast Pump (Model S12) | Shenzhen TPH Technology Co., Ltd. | 2022 | — |
| +2 | K242850 | Wearable breast pump (model W8) | Shenzhen TPH Technology Co., Ltd. | 2025 | — |
| +2 | K240536 | Wearable Breast Pump (Model S32) | Shenzhen TPH Technology Co., Ltd. | 2024 | — |
| +3 | K252420 | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | 2026 | — |
| +2 | K250383 | Wearable Breast Pump (Model W6) | 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 | 2 | 0 |
| 2023 | 3 | 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 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 |
|---|---|---|---|
| * | K161266 | Athena Breast PumpSummary page 4…ber: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Product Code: HGX (Pump, Breast, Powered) Predicate Device: Athena Breast Pump (K161266) The predicate device has not been subject to a design-related recall. Device Description: The Wi… | 2016 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 39 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K212180 (Shenzhen TPH Technology Co., Ltd., 2022) has gone furthest, with 25 descendants of its own.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Willow Wearable Breast Pump 2.0 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/K191577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191577: Willow Wearable Breast Pump 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191577
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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