510(k) · Cleared
ClearedFreemie (R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dao Health · HGX Pump, Breast, Powered
Cleared on Feb 1, 2012 as substantially equivalent to K031614 (Medela, Inc., 2003) and 1 other predicate after a 257-day review. Its family tree reaches back 3 generations to 1980. 2 later devices descend from it.
- Decided
- Feb 1, 2012
- Review
- 257 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K801862 (1980). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 2 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 1 generation backK031614 Medela Pump in Style Advanced Breast PumpMedela, Inc. · 2003 · Recalled
- This deviceK111411 Freemie (R)Dao Health · 2012
- Descendant · cites it directly · 1 of its ownK130349 Freemie Breast Collection SystemDao Health · 2013
- Descendant · 2 generations on · 0 of its ownK170722 Moxxly Flow Collection SystemMoxxly, Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −2 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −1 | K031614 | Medela Pump in Style Advanced Breast Pump | Medela, Inc. | 2003 | 1 |
| 0 (this device) | K111411 | Freemie (R) | Dao Health | 2012 | — |
| +1 | K130349 | Freemie Breast Collection System | Dao Health | 2013 | — |
| +2 | K170722 | Moxxly Flow Collection System | Moxxly, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031614 | Medela Pump in Style Advanced Breast PumpSummary page 1…evice Classification Product Code: 85 HGX 884.5160 Predicate Device(s) Medela® Pump in Style® Advanced Breastpump, (K03 1614) Learning Curve Brands miPUMpTM (K082802) Performance standards h… | 2003 |
| * | K082802 | Mipump Single Electric/Battery Breat Pump & Mipump Double Electric/Battery Breast Pump &…Summary page 1…884.5160 Predicate Device(s) Medela® Pump in Style® Advanced Breastpump, (K03 1614) Learning Curve Brands miPUMpTM (K082802) Performance standards have not been promulgated for powered breast Performance Standards… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130349 | Freemie Breast Collection System | 2013 | 1 |
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 32 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K130349 (Dao Health, 2013) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K031614.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Freemnie breast pump collection system is intended td be used in conjunction with an approved electric breast pump for the purpose of expressing human milk.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111411 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111411: Freemie (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111411
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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