510(k) · Cleared
ClearedPump In Style Advanced, Advanced Personal Double Breastpump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela, LLC · HGX Pump, Breast, Powered
Cleared on Oct 16, 2018 as substantially equivalent to K031614 (Medela, Inc., 2003) after an 89-day review. Its family tree reaches back 3 generations to 1980. 10 later devices descend from it.
- Decided
- Oct 16, 2018
- Review
- 89 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K801862 (1980). 5 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 2 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 1 generation backK031614 Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003 · Recalled
- This deviceK181937 Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC · 2018
- Descendant · cites it directly · 8 of its ownK200508 Pump In StyleMedela, LLC · 2020
- Descendant · 2 generations on · 4 of its ownK213311 Lucy Breast PumpWillow Innovations, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK251377 Magic InBraMedela AG · 2025
- Descendant · 3 generations on · 1 of its ownK243508 Wearable breast pump (model S12A)Shenzhen TPH Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK261622 Philips Avent Natural Care Hands-free Wearable Electric Breast Pump…Philips Consumer Lifestyle B.V. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K200508Pump In StyleMedela, LLC · 2020 · cites it directly8descendants
- K213311Lucy Breast PumpWillow Innovations, Inc. · 2022 · 2 generations on4descendants
- K251377Magic InBraMedela AG · 2025 · 2 generations on1descendant
- K243508Wearable breast pump (model S12A)Shenzhen TPH Technology Co., Ltd. · 2025 · 3 generations on1descendant
- K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…Philips Consumer Lifestyle B.V. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −2 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −1 | K031614 | Medela Pump in Style Advanced Breast Pump | Medela, Inc. | 2003 | 1 |
| 0 (this device) | K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | Medela, LLC | 2018 | — |
| +1 | K200508 | Pump In Style | Medela, LLC | 2020 | — |
| +2 | K213311 | Lucy Breast Pump | Willow Innovations, Inc. | 2022 | — |
| +2 | K251377 | Magic InBra | Medela AG | 2025 | — |
| +3 | K243508 | Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. | 2025 | — |
| +3 | K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… | Philips Consumer Lifestyle B.V. | 2026 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K031614 | Medela Pump in Style Advanced Breast PumpSummary page 4…Breast, Powered Product Code: HGX Regulatory Class: II Predicate Device Information K031614 Manufacturer: Medela Device Name: Pump In Style® Advanc… | 2003 |
What descends from it? (10)
2 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 38 years and passes through 2 companies; a new generation was cleared every 15.4 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K200508 (Medela, LLC, 2020) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K031614.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Pump In Style® Advanced breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The powered breast pump is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181937: Pump In Style Advanced, Advanced Personal Double Breastpump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181937
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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