510(k) Report

510(k) · Cleared

Cleared

Youha electric breast pump

K163136510(k) TraditionalCleared Jul 31, 2017265-day reviewClass II21 CFR 884.5160

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ningbo Youhe Electrical Appliance Technology Co., Ltd. · HGX Pump, Breast, Powered

Cleared on Jul 31, 2017 as substantially equivalent to K162415 (Uzinmedicare Company, 2017) after a 265-day review. Its family tree reaches back 5 generations to 1980. 30 later devices descend from it.

Decided
Jul 31, 2017
Review
265 days
Class
Class II
Product code
HGX
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K801862 (1980). 9 ancestors in all. 30 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor2021: 3 descendants cleared2024: 6 descendants cleared2022: 2 descendants cleared2026: 11 descendants cleared2023: 2 descendants cleared2025: 6 descendants clearedK801862 · Medela Electric Breast Pump · Medela, Inc. · 1980 · recalledK020518 · Medela Symphony Breast Pump, Model 024 · Medela, Inc. · 2002 · recalledK053052 · Medela Swing Breast Pump · Medela AG · 2006K092783 · DEBP · Enko, Ltd. · 2009K162415 · Spectra 9Plus · Uzinmedicare Company · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant5 generations forward: 7 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K162415 · Spectra 9Plus · Uzinmedicare Company · 2017K092783 · DEBP · Enko, Ltd. · 2009K053052 · Medela Swing Breast Pump · Medela AG · 2006K020518 · Medela Symphony Breast Pump, Model 024 · Medela, Inc. · 2002 · recalledK801862 · Medela Electric Breast Pump · Medela, Inc. · 1980 · recalled−50+5
  1. Root · 5 generations backK801862 Medela Electric Breast PumpMedela, Inc. · 1980 · Recalled
  2. 4 generations backK020518 Medela Symphony Breast Pump, Model 024Medela, Inc. · 2002 · Recalled
  3. 3 generations backK053052 Medela Swing Breast PumpMedela AG · 2006
  4. 2 generations backK092783 DEBPEnko, Ltd. · 2009
  5. 1 generation backK162415 Spectra 9PlusUzinmedicare Company · 2017
  6. This deviceK163136 Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. · 2017
  7. Descendant · cites it directly · 21 of its ownK201903 Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd. · 2021
  8. Descendant · 2 generations on · 14 of its ownK222782 Wearable Breast Pump…Zhejiang Carebao Co., Ltd. · 2023
  9. Descendant · 3 generations on · 12 of its ownK232466 Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd. · 2024
  10. Descendant · 4 generations on · 11 of its ownK241322 Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 2024
  11. Descendant · 5 generations on · 4 of its ownK251394 Momcozy Wearable Breast Pump (BP223)Shenzhen Root Innovation Technology Co., Ltd. · 2025

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2021: 32022: 22023: 22024: 62025: 62026: 11
2021high 11 (2026) · low 2 (2022)2026

Most influential descendants

Showing 5 of 30 · See all
  • K201903Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd. · 2021 · cites it directly21descendants
  • K222782Wearable Breast Pump…Zhejiang Carebao Co., Ltd. · 2023 · 2 generations on14descendants
  • K232466Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd. · 2024 · 3 generations on12descendants
  • K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 2024 · 4 generations on11descendants
  • K251394Momcozy Wearable Breast Pump (BP223)Shenzhen Root Innovation Technology Co., Ltd. · 2025 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K801862Medela Electric Breast PumpMedela, Inc.19801
−4K020518Medela Symphony Breast Pump, Model 024Medela, Inc.20023
−3K053052Medela Swing Breast PumpMedela AG2006—
−2K092783DEBPEnko, Ltd.2009—
−1K162415Spectra 9PlusUzinmedicare Company2017—
0 (this device)K163136Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd.2017—
+1K201903Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd.2021—
+2K222782Wearable Breast Pump…Zhejiang Carebao Co., Ltd.2023—
+3K232466Electric Breast Pump, model: YM-8166Guangdong Youmeng Electrical Technology Co., Ltd.2024—
+4K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd.2024—
+5K251394Momcozy Wearable Breast Pump (BP223)Shenzhen Root Innovation Technology Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199510
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202130
202220
202320
202460
202560
2026110
FIG. 1 — Lineage of K163136, 1980–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212180 Wearable Breast Pump (Model S12)score 34.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K162415Spectra 9Plus
Cleared while this submission was under review
Summary page 4
…0, Powered breast pump Review Panel: Obstetrics/Gynecology Product Code: HGX (pump, breast, powered) 4. Predicate Device 510(k): K162415 Device Name: Spectra 9 Plus powered breast pump Manufacturer: Uzinmedicare Company 5. Device Description The Y…
Uzinmedicare Company2017—

Also cleared against K162415: 1 other device →

What descends from it? (30)

See all 30

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201903Electric breast pump (Models: RH-228 and RH-338)Cixi Ruihong Electric Appliance Co., Ltd.202121
K240218Electric Breast Pump (F5055)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.20243
K211755Electric Breast PumpZhejiang Carebao Co., Ltd.20211
K220309Wearable Breast Pump (Model S10)Shenzhen Lutejiacheng Technology Co., Ltd.20220
K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030)…Ningbo Youhe Electrical Appliance Technology Co., Ltd.20210

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 37 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
  • 4 of the 9 ancestors have a recall of any class.
  • Of its descendants, K201903 (Cixi Ruihong Electric Appliance Co., Ltd., 2021) has gone furthest, with 21 descendants of its own.
  • 1 other device also cites its predicate K162415.

How does its category compare?

All HGX devices

HGX Pump, Breast, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HGX

34so far in 2026, the most since 2007

2007: 12008: 22009: 42010: 72011: 22012: 62013: 42014: 32015: 92016: 72017: 82018: 62019: 72020: 92021: 122022: 152023: 152024: 192025: 262026 (partial year): 34
2007high 34 (2026) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGX

122in 2025

2009: 121 days median2010: 103 days median2012: 180 days median2013: 131 days median2014: 120 days median2015: 141 days median2016: 121 days median2017: 159 days median2018: 136 days median2019: 158 days median2020: 128 days median2021: 240 days median2022: 190 days median2023: 167 days median2024: 168 days median2025: 122 days median2026 (partial year): 142 days median
2007high 240 (2021) · low 103 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HGX

1in 2017

2010: 52011: 12017: 1
2007high 5 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HGX

69in 2025

2007: 22008: 22010: 882011: 2402012: 6852013: 8372014: 1,0362015: 4962016: 3732017: 4372018: 2912019: 1682020: 1682021: 1192022: 1542023: 2002024: 1182025: 69
2007high 1,036 (2014) · low 0 (2009)2025

MAUDE reports naming product code HGX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20082—02
2009412100
20107103588
20112—1240
201261800685
201341310837
2014312001,036
201591410496
201671210373
201781591437
201861360291
201971580168
202091280168
2021122400119
2022151900154
2023151670200
2024191680118
202526122069
2026341420—

What is it indicated for?

The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts.

It is intended for a single user.

Indications for use as stated in the FDA summary.

Also cleared against K162415

1 other device cites the same predicate.

  • K191109Spectra QUzinmedicare Co. · 2020

More from Ningbo Youhe Electrical Appliance…

4 FDA decisions under this applicant name. See the company

  • K251977electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2025
  • K242725Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump…Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2025
  • K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast…Ningbo Youhe Electrical Appliance Technology Co., Ltd. · 2021

Recent decisions in HGX

The HGX category page

  • K261782MODO DUO Electric Pump (B11621, B11673)Tomy International, Inc. · 2026
  • K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd. · 2026
  • K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips…Philips Consumer Lifestyle B.V. · 2026
  • K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd. · 2026
  • K260643Cimilre Dual MaxCimilre Co., Ltd. · 2026

https://510kreport.com/device/K163136 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163136: Youha electric breast pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163136

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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