510(k) · Cleared
Recalled · 2011Medela Pump in Style Advanced Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela, Inc. · HGX Pump, Breast, Powered
Cleared on Jun 6, 2003 as substantially equivalent to K020518 (Medela, Inc., 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1980. 21 later devices descend from it. It has been recalled once.
- Decided
- Jun 6, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- HGX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801862 (1980). 4 ancestors in all. 21 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 1 generation backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- This deviceK031614 Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003
- Descendant · cites it directly · 10 of its ownK181937 Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC · 2018
- Descendant · 2 generations on · 8 of its ownK200508 Pump In StyleMedela, LLC · 2020
- Descendant · 3 generations on · 4 of its ownK213311 Lucy Breast PumpWillow Innovations, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK111411 Freemie (R)Dao Health · 2012
- Descendant · cites it directly · 2 of its ownK102516 Lucina Model MelodiGenadyne Biotechnologies, Inc. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K181937Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC · 2018 · cites it directly10descendants
- K200508Pump In StyleMedela, LLC · 2020 · 2 generations on8descendants
- K213311Lucy Breast PumpWillow Innovations, Inc. · 2022 · 3 generations on4descendants
- K111411Freemie (R)Dao Health · 2012 · cites it directly2descendants
- K102516Lucina Model MelodiGenadyne Biotechnologies, Inc. · 2011 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −1 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| 0 (this device) | K031614 | Medela Pump in Style Advanced Breast Pump | Medela, Inc. | 2003 | — |
| +1 | K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | Medela, LLC | 2018 | — |
| +2 | K200508 | Pump In Style | Medela, LLC | 2020 | — |
| +3 | K213311 | Lucy Breast Pump | Willow Innovations, Inc. | 2022 | — |
| +1 | K111411 | Freemie (R) | Dao Health | 2012 | — |
| +1 | K102516 | Lucina Model Melodi | Genadyne Biotechnologies, Inc. | 2011 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K020518 | Medela Symphony Breast Pump, Model 024 | 2002 |
| * | K950750 | Medelas Breast PumpSummary page 1…er 21 CFR section 884.5160). 3. Name of Predicate Device(s): Medela@Symphony@Breast Pump, by Medela Inc., KO20518 Medela@Pump in Style@Breastpump, by Medela Inc., K950750 4. Description of Device: The Medela@Pump in Style@AdvancedBreastpump is intended to express the mother's milk of a lactating w… | 1995 |
What descends from it? (21)
See all 217 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | 2018 | 10 |
| K111411 | Freemie (R) | 2012 | 2 |
| K102516 | Lucina Model Melodi | 2011 | 2 |
| K130349 | Freemie Breast Collection System | 2013 | 1 |
| K052047 | Isis IQ Uno Handheld Electronic Breast Pump, Model 101 | 2005 | 1 |
| K051413 | Isis IQ Duo Twin Electronic Breast Pump, Model 100 | 2005 | 0 |
| K043098 | Gerber Double Electric Breast Pump | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2011 | Not classified | Z-1224-2011 | Vendor change control | The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 21.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K181937 (Medela, LLC, 2018) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K020518.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031614: Medela Pump in Style Advanced Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031614
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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