Cleared Traditional

K261298 - Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

K261298 is an FDA 510(k) clearance for Wearable Electric Breast Pump (YM-8837, manufactured by Guangdong Youmeng Electrical Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K261298 · Guangdong Youmeng Electrical Technology Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Aug 2026
Decision
122d
Days
Class 2
Risk

K261298 is an FDA 510(k) clearance for the Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Guangdong Youmeng Electrical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on August 20, 2026 after a review of 122 days - within the typical 510(k) review window.

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 Guangdong Youmeng Electrical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K261298

510(k) Number K261298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2026
Decision Date August 20, 2026
Days to Decision 122 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 160d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGX Device Classification - Class 2, Special Controls

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

ABMED Medical Technology PTY, Ltd.
Boyle Wang

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 202
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K261298.
Cimilre Dual Max
K260643 · Cimilre Co., Ltd. · Aug 2026
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
K260259 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Wearable Breast Pump (Model S32A)
K261199 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
K250070 · Shenzhen Changkun Technology Co., Ltd. · Jun 2026
Wearable breast pump (QY-101, QY-102, QY-108)
K261025 · Shenzhen Qinyi Electronic Technology Co., Ltd. · Jun 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
K254254 · Shenzhen Root Innovation Technology Co., Ltd. · Jun 2026