510(k) · Cleared
Recalled · 2010Medela Symphony Breast Pump, Model 024
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 Mar 7, 2002 as substantially equivalent to K801862 (Medela, Inc., 1980) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 1980. 139 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 7, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- HGX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K801862 (1980). 2 ancestors in all. 139 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- This deviceK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002
- Descendant · cites it directly · 105 of its ownK053052 Medela Swing Breast PumpMedela AG · 2006
- Descendant · 2 generations on · 100 of its ownK092783 DEBPEnko, Ltd. · 2009
- Descendant · 3 generations on · 63 of its ownK122474 Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012
- Descendant · 4 generations on · 55 of its ownK150499 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle…Medela AG · 2015
- Descendant · 3 generations on · 32 of its ownK162415 Spectra 9PlusUzinmedicare Company · 2017
Showing 5 of 139 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 139 · See all- K053052Medela Swing Breast PumpMedela AG · 2006 · cites it directly105descendants
- K092783DEBPEnko, Ltd. · 2009 · 2 generations on100descendants
- K122474Lansinoh Powered Electric Breast PumpLansinoh Laboratories Saglik Gerecleri Tasarim San · 2012 · 3 generations on63descendants
- K150499Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyMedela AG · 2015 · 4 generations on55descendants
- K162415Spectra 9PlusUzinmedicare Company · 2017 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| 0 (this device) | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | — |
| +1 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| +2 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| +3 | K122474 | Lansinoh Powered Electric Breast Pump | Lansinoh Laboratories Saglik Gerecleri Tasarim San | 2012 | — |
| +4 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor… | Medela AG | 2015 | — |
| +3 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 22 | 0 |
| 2026 | 28 | 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 |
|---|---|---|---|
| * | K801862 | Medela Electric Breast PumpSummary page 1…sification Name: Powered Breast Pump (Classified Class I, per 21 CFR section 884.5160). 3. Name of Predicate Device(s): e Medela® Classic™ Breast Pump, by Medela Inc., K801862 o Egnell Elite Breast Pump, by Ameda Medizintechnik AG (Hollister Inc.), K950531 M:\Symphony\New510(k)Symphony\Section E_a.doc… | 1980 |
| * | K950531 | Egnell EliteSummary page 1…160). 3. Name of Predicate Device(s): e Medela® Classic™ Breast Pump, by Medela Inc., K801862 o Egnell Elite Breast Pump, by Ameda Medizintechnik AG (Hollister Inc.), K950531 M:\Symphony\New510(k)Symphony\Section E_a.doc 11.01.2002 E-10f2 Koaos|8 Applicant: Medela Inc., 1101 Corporate… | 1995 |
What descends from it? (139)
See all 1396 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053052 | Medela Swing Breast Pump | 2006 | 105 |
| K031614 | Medela Pump in Style Advanced Breast Pump | 2003 | 21 |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus… | 2015 | 4 |
| K141742 | Ardo Carum and Calypso Powered Breast Pumps | 2014 | 3 |
| K100435 | Ameda Platinum Breast Pump | 2010 | 1 |
| K112856 | Lucina-Melodi | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2010 | Not classified | Z-2484-2010 | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| Aug 6, 2010 | Not classified | Z-2483-2010 | Packaging | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| Mar 15, 2010 | Not classified | Z-1442-2010 | Labeling Change Control | The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K053052 (Medela AG, 2006) has gone furthest, with 105 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.
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 Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020518 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020518: Medela Symphony Breast Pump, Model 024.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020518
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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