510(k) · Cleared
ClearedLucy Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Willow Innovations, Inc. · HGX Pump, Breast, Powered
Cleared on Feb 9, 2022 as substantially equivalent to K200508 (Medela, LLC, 2020) after a 128-day review. Its family tree reaches back 5 generations to 1980. 4 later devices descend from it.
- Decided
- Feb 9, 2022
- Review
- 128 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801862 (1980). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 4 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 3 generations backK031614 Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003 · Recalled
- 2 generations backK181937 Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC · 2018
- 1 generation backK200508 Pump In StyleMedela, LLC · 2020
- This deviceK213311 Lucy Breast PumpWillow Innovations, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK243508 Wearable breast pump (model S12A)Shenzhen TPH Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261025 Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253149 Motion InBra (YM-8801) wearable breast pumpMedela, LLC · 2026
- Descendant · cites it directly · 0 of its ownK250350 Thrive 2-in-1 Breast Pump (Model P3)Shenzhen TPH Technology Co., Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K243508Wearable breast pump (model S12A)Shenzhen TPH Technology Co., Ltd. · 2025 · cites it directly1descendant
- K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K253149Motion InBra (YM-8801) wearable breast pumpMedela, LLC · 2026 · cites it directly0descendants
- K250350Thrive 2-in-1 Breast Pump (Model P3)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 |
|---|---|---|---|---|---|
| −5 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −4 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −3 | K031614 | Medela Pump in Style Advanced Breast Pump | Medela, Inc. | 2003 | 1 |
| −2 | K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | Medela, LLC | 2018 | — |
| −1 | K200508 | Pump In Style | Medela, LLC | 2020 | — |
| 0 (this device) | K213311 | Lucy Breast Pump | Willow Innovations, Inc. | 2022 | — |
| +1 | K243508 | Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. | 2025 | — |
| +2 | K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | 2026 | — |
| +1 | K253149 | Motion InBra (YM-8801) wearable breast pump | Medela, LLC | 2026 | — |
| +1 | K250350 | Thrive 2-in-1 Breast Pump (Model P3) | Shenzhen TPH Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K200508 | Pump In StyleSummary page 4…CATE DEVICE INFORMATION Predicate Name: Pump In Style® Predicate Manufacturer: Medela LLC 510(k) Number: K200508 The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Lucy Breast Pu… | 2020 |
What descends from it? (4)
3 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 42 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K243508 (Shenzhen TPH Technology Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K200508.
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 Lucy Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Lucy Breast Pump is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213311 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213311: Lucy Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213311
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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