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510(k) K251977

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) by Ningbo Youhe Electrical Appliance Technology Co., Ltd. — Product Code HGX

K251977 is an FDA 510(k) premarket notification submitted by Ningbo Youhe Electrical Appliance Technology Co., Ltd. for the device "electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)". The FDA issued a decision of Substantially Equivalent on Oct 22, 2025. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Ningbo Youhe Electrical Appliance Technology Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 22, 2025
Date Received
Jun 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Ningbo Youhe Electrical Appliance Technology Co., Ltd.

  • K242725 — Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BE (May 30, 2025)
  • K203148 — Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030) (Jul 8, 2021)
  • K163136 — Youha electric breast pump (Jul 31, 2017)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (Jun 18, 2026)

FDA data resources