510(k) · Cleared
ClearedMedela Swing Breast Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · HGX Pump, Breast, Powered
Cleared on May 2, 2006 as substantially equivalent to K020518 (Medela, Inc., 2002) and 1 other predicate after a 183-day review. Its family tree reaches back 2 generations to 1980. 105 later devices descend from it.
- Decided
- May 2, 2006
- Review
- 183 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801862 (1980). 4 ancestors in all. 105 later devices descend from it, 5 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 deviceK053052 Medela Swing Breast PumpMedela AG · 2006
- Descendant · cites it directly · 100 of its ownK092783 DEBPEnko, Ltd. · 2009
- Descendant · 2 generations on · 63 of its ownK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- Descendant · 3 generations on · 55 of its ownK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- Descendant · 2 generations on · 32 of its ownK162415 Spectra 9PlusUzinmedicare Company · 2017
- Descendant · 3 generations on · 30 of its ownK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K092783DEBPEnko, Ltd. · 2009 · cites it directly100descendants
- K122474Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012 · 2 generations on63descendants
- K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyMedela AG · 2015 · 3 generations on55descendants
- K162415Spectra 9PlusUzinmedicare Company · 2017 · 2 generations on32descendants
- K163136Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017 · 3 generations on30descendants
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) | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| +1 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| +2 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| +3 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| +2 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| +3 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 24 | 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 024Summary page 1…Classification Name: Powered Breast Pump (Classified Class II, per 21 CFR Section 884.5160) 3. Name of Predicate Device: MedelaeSymphony® Breastpump, by Medela AG, K020518 Medela® Mini Electric® Breastpump, by Medela AG, K901344 4. Description of Device: The Medela®SwingTM Breastpump is intended… | 2002 |
| * | K901344 | Medela Battery Operated Breast PumpSummary page 1…lass II, per 21 CFR Section 884.5160) 3. Name of Predicate Device: MedelaeSymphony® Breastpump, by Medela AG, K020518 Medela® Mini Electric® Breastpump, by Medela AG, K901344 4. Description of Device: The Medela®SwingTM Breastpump is intended to express the mother's milk of a lactating woman. The pu… | 1990 |
What descends from it? (105)
See all 1055 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 26 years and passes through 2 companies; a new generation was cleared every 21.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K092783 (Enko, Ltd., 2009) has gone furthest, with 100 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 SwingTM 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/K053052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053052: Medela Swing Breast Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053052
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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