Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

K-Number: K251977 · 2025-10-22

ApplicantNingbo Youhe Electrical Appliance Technology Co., Ltd.
Decision Date2025-10-22
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is a medical device manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-22 under approval number K251977. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K251977.

When was electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) approved by the FDA?

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) received FDA 510(k) clearance on 2025-10-22, under approval number K251977.

What company makes electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is manufactured by Ningbo Youhe Electrical Appliance Technology Co., Ltd..

What is the FDA product code for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

The FDA product code for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is HGX.

Related Clinical Trials

NCT05746325 Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer RECRUITING

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

K163136Youha electric breast pump K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030) K242725Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑