510(k) · Cleared
ClearedSymphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
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 Nov 5, 2015 as substantially equivalent to K020518 (Medela, Inc., 2002) after a 141-day review. Its family tree reaches back 2 generations to 1980. 4 later devices descend from it.
- Decided
- Nov 5, 2015
- Review
- 141 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801862 (1980). 3 ancestors in all. 4 later devices descend from it, 2 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 deviceK151632 Symphony Breastpump, Symphony reconditioned, Symphony Preemie+…Medela AG · 2015
- Descendant · cites it directly · 2 of its ownK160511 Naya Breast Pump SystemNaya Health, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK173699 The Pump by BabyationBabyation, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK162747 Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK161725 Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping…Medela, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K160511Naya Breast Pump SystemNaya Health, Inc. · 2016 · cites it directly2descendants
- K173699The Pump by BabyationBabyation, LLC · 2018 · 2 generations on0descendants
- K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2016 · 2 generations on0descendants
- K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail…Medela, Inc. · 2016 · cites it directly0descendants
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) | K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump… | Medela AG | 2015 | — |
| +1 | K160511 | Naya Breast Pump System | Naya Health, Inc. | 2016 | — |
| +2 | K173699 | The Pump by Babyation | Babyation, LLC | 2018 | — |
| +2 | K162747 | Proture Double Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2016 | — |
| +1 | K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing… | Medela, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 3 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K020518 | Medela Symphony Breast Pump, Model 024Summary page 6…PRODUCT CODE: HGX Medela AG Symphony Breast Pump PREDICATE DEVICE(S): K020518 Medela Symphony Breast Pump Model 024 DEVICE DESCRIPTION: The Symphony breast pump is intended to be used by lactating women to… | 2002 |
What descends from it? (4)
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 35 years and passes through 2 companies; a new generation was cleared every 21.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K160511 (Naya Health, Inc., 2016) has gone furthest, with 2 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. 2015, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K151632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151632: Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151632
Report an extraction error
Are you the manufacturer?
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