510(k) · Cleared
ClearedMomcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Root Innovation Technology Co., Ltd. · HGX Pump, Breast, Powered
Cleared on Mar 9, 2026 as substantially equivalent to K251394 (Shenzhen Root Innovation Technology Co., Ltd., 2025) after a 90-day review. Its family tree reaches back 11 generations to 1980.
- Decided
- Mar 9, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- HGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K801862 (1980). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 7 generations between
- 3 generations backK232466 Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd. · 2024
- 2 generations backK241322 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 2024
- 1 generation backK251394 Momcozy Wearable Breast Pump (BP223)Shenzhen Root Innovation Technology Co., Ltd. · 2025
- This deviceK253934 Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5…Shenzhen Root Innovation Technology Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
- 10 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
- 9 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
- 8 generations backK092783 DEBPEnko, Ltd. · 2009
- 7 generations backK162415 Spectra 9PlusUzinmedicare Company · 2017
- 6 generations backK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
- 5 generations backK201903 Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd. · 2021
- 4 generations backK222782 Wearable Breast Pump…Zhejiang Carebao Co., Ltd. · 2023
- 3 generations backK232466 Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd. · 2024
- 2 generations backK241322 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 2024
- 1 generation backK251394 Momcozy Wearable Breast Pump (BP223)Shenzhen Root Innovation Technology Co., Ltd. · 2025
- This deviceK253934 Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5…Shenzhen Root Innovation Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K801862 | Medela Electric Breast Pump | Medela, Inc. | 1980 | 1 |
| −10 | K020518 | Medela Symphony Breast Pump, Model 024 | Medela, Inc. | 2002 | 3 |
| −9 | K053052 | Medela Swing Breast Pump | Medela AG | 2006 | — |
| −8 | K092783 | DEBP | Enko, Ltd. | 2009 | — |
| −7 | K162415 | Spectra 9Plus | Uzinmedicare Company | 2017 | — |
| −6 | K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017 | — |
| −5 | K201903 | Electric breast pump (Models: RH-228 and RH-338) | Cixi Ruihong Electric Appliance Co., Ltd. | 2021 | — |
| −4 | K222782 | Wearable Breast Pump… | Zhejiang Carebao Co., Ltd. | 2023 | — |
| −3 | K232466 | Electric Breast Pump, model: YM-8166 | Guangdong Youmeng Electrical Technology Co., Ltd. | 2024 | — |
| −2 | K241322 | Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | Joytech Healthcare Co., Ltd. | 2024 | — |
| −1 | K251394 | Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. | 2025 | — |
| 0 (this device) | K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A… | Shenzhen Root Innovation Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K251394 | Momcozy Wearable Breast Pump (BP223)Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Device Trade Name Product Code K251394 Momcozy Wearable Breast Pump (BP223) HGX The predicate device has not been… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 46 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K251394.
How does its category compare?
All HGX devicesHGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Momcozy Wearable Breast Pump (Model: BP380,BP380-A,BP380-B,BP380-C,M5,M5-A,M5-B,M5-C) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253934 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253934: Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253934
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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