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510(k) K223329

Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) by Guangzhou Yongyi Industrial Co., Ltd. — Product Code HGX

K223329 is an FDA 510(k) premarket notification submitted by Guangzhou Yongyi Industrial Co., Ltd. for the device "Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)". The FDA issued a decision of Substantially Equivalent on May 26, 2023. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Guangzhou Yongyi Industrial Co., Ltd. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2023
Date Received
Oct 31, 2022
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
510(k)

Other clearances by Guangzhou Yongyi Industrial Co., Ltd.

  • K192640 — Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump (Mar 30, 2020)

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… (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