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FDA 510(k)

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

K-Number: K250207 · 2025-08-11

ApplicantAnker Innovations Limited
Decision Date2025-08-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is the device name listed in this FDA 510(k) record. The listed applicant is Anker Innovations Limited. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K250207. 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 eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Anker Innovations Limited. The 510(k) number is K250207.

When did eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) receive FDA 510(k) clearance?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K250207.

Who is the listed applicant for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

The FDA 510(k) record lists Anker Innovations Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

The FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is HGX.

Other records listing Anker Innovations Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254300eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

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.

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