Cleared Traditional

eufy Wearable Breast Pump S1 (T8D02) (K250207) - FDA 510(k) Clearance

Also marketed or referenced as:
eufy Wearable Breast Pump E10 (T8D03)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250207 · Anker Innovations Limited · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
199d
Days
Class 2
Risk

K250207 is an FDA 510(k) clearance for the eufy Wearable Breast Pump S1 (T8D02). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Anker Innovations Limited (Hong Kong, CN). The FDA issued a Cleared decision on August 11, 2025 after a review of 199 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Anker Innovations Limited devices

Submission Details

510(k) Number K250207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2025
Decision Date August 11, 2025
Days to Decision 199 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 160d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Tracy Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K250207.
Wearable Breast Pump (Model S33)
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Wearable Breast Pump (Model W6)
K250383 · Shenzhen TPH Technology Co., Ltd. · Aug 2025
Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
K252192 · Huizhou Lvb Maternal and Infant Supplies Co., Ltd. · Aug 2025
Wearable Breast Pump (Model FS12A)
K250843 · Shenzhen TPH Technology Co., Ltd. · Jul 2025
Thrive 2-in-1 Breast Pump (Model P3)
K250350 · Shenzhen TPH Technology Co., Ltd. · Jul 2025
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
K242725 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · May 2025