510(k) · Cleared
ClearedMipump Single Electric/Battery Breat Pump & Mipump Double Electric/Battery Breast Pump & Mipump Deluxe Double Electric/B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Learning Curve Brands Inc. the First Years · HGX Pump, Breast, Powered
Cleared on Oct 9, 2008 after a 15-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Oct 9, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK082802 Mipump Single Electric/Battery Breat Pump & Mipump Double…Learning Curve Brands Inc. the First Years · 2008
- Descendant · cites it directly · 2 of its ownK111411 Freemie (R)Dao Health · 2012
- Descendant · 2 generations on · 1 of its ownK130349 Freemie Breast Collection SystemDao Health · 2013
- Descendant · 3 generations on · 0 of its ownK170722 Moxxly Flow Collection SystemMoxxly, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK101157 E-Basic Single Breast PumpMapa GmbH · 2010
Most influential descendants
Showing 4 of 4 · See all- K111411Freemie (R)Dao Health · 2012 · cites it directly2descendants
- K130349Freemie Breast Collection SystemDao Health · 2013 · 2 generations on1descendant
- K170722Moxxly Flow Collection SystemMoxxly, Inc. · 2017 · 3 generations on0descendants
- K101157E-Basic Single Breast PumpMapa GmbH · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082802 | Mipump Single Electric/Battery Breat Pump & Mipump Double Electric/Battery… | Learning Curve Brands Inc. the First Years | 2008 | — |
| +1 | K111411 | Freemie (R) | Dao Health | 2012 | — |
| +2 | K130349 | Freemie Breast Collection System | Dao Health | 2013 | — |
| +3 | K170722 | Moxxly Flow Collection System | Moxxly, Inc. | 2017 | — |
| +1 | K101157 | E-Basic Single Breast Pump | Mapa GmbH | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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?
The FDA summary names no predicate by number.
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?
- Of its descendants, K111411 (Dao Health, 2012) has gone furthest, with 2 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. 2008, 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?
Powered Breast Pump to express milk from the breast.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082802: Mipump Single Electric/Battery Breat Pump & Mipump Double Electric/Battery Breast Pump & Mipump Deluxe Double Electric/B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082802
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