510(k) · Cleared
ClearedMegna Breast Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuxi Xinzhongrui Baby Supplies Co., Ltd. · HGX Pump, Breast, Powered
Cleared on Feb 24, 2015 as substantially equivalent to K113664 (Mayborn Group Limited, 2012) after a 173-day review. Its family tree reaches back 3 generations to 1988. 3 later devices descend from it.
- Decided
- Feb 24, 2015
- Review
- 173 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K875300 (1988). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK875300 Medela Breast-Pump LactinaMedela, Inc. · 1988 · Recalled
- 2 generations backK973501 Expresse and Premier Powered Breast PumpsAmeda Medizintechnik AG · 1997 · Recalled
- 1 generation backK113664 Closer to Nature Electric Breast PumpMayborn Group Limited · 2012
- This deviceK142479 Megna Breast PumpsWuxi Xinzhongrui Baby Supplies Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK151284 Electric Double Breast PumpsWuxi Xinzhongrui Baby Supplies Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK202802 TT Electric Breast Pump, TT Double Electric Breast PumpWuxi Xinzhongrui Baby Supplies Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK191802 Electric Breast PumpNingbo Huiyoo Baby Products Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See all- K151284Electric Double Breast PumpsWuxi Xinzhongrui Baby Supplies Co., Ltd. · 2015 · cites it directly1descendant
- K202802TT Electric Breast Pump, TT Double Electric Breast PumpWuxi Xinzhongrui Baby Supplies Co., Ltd. · 2021 · cites it directly0descendants
- K191802Electric Breast PumpNingbo Huiyoo Baby Products Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875300 | Medela Breast-Pump Lactina | Medela, Inc. | 1988 | 3 |
| −2 | K973501 | Expresse and Premier Powered Breast Pumps | Ameda Medizintechnik AG | 1997 | 1 |
| −1 | K113664 | Closer to Nature Electric Breast Pump | Mayborn Group Limited | 2012 | — |
| 0 (this device) | K142479 | Megna Breast Pumps | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015 | — |
| +1 | K151284 | Electric Double Breast Pumps | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2015 | — |
| +1 | K202802 | TT Electric Breast Pump, TT Double Electric Breast Pump | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2021 | — |
| +2 | K191802 | Electric Breast Pump | Ningbo Huiyoo Baby Products Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K113664 | Closer to Nature Electric Breast PumpSummary page 4…sification Name: Powered Breast Pump Panel: Obstetrics/Gynecology Product Code: HGX Predicate Device: K113664, Closer to Nature Electric Breast Pump Indication for Use: The powered Megna Breast Pumps are intended to express and collect m… | 2012 |
What descends from it? (3)
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 27 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K151284 (Wuxi Xinzhongrui Baby Supplies Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K113664.
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 powered Megna Breast Pumps are intended to express and collect milk from the breast of a lactating woman.
The M5 model is a single pump. The M7, MIO, and M12 models are double pumps with a single pumping option. All models are intended for single users.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142479: Megna Breast Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142479
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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