Cleared Traditional

K252342 - Electric Breast Pump (YM-8807

K252342 is an FDA 510(k) clearance for Electric Breast Pump (YM-8807, 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 144-day FDA review.

K252342 · Guangdong Youmeng Electrical Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
144d
Days
Class 2
Risk

K252342 is an FDA 510(k) clearance for the Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810). 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 December 19, 2025 after a review of 144 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 - K252342

510(k) Number K252342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2025
Decision Date December 19, 2025
Days to Decision 144 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
16d faster than avg
Panel avg: 160d · This submission: 144d
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

Shanghai Truthful Information Technology Co., 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 135
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K252342.
Spectra S1 Pro
K251423 · Uzinmedicare Co., Ltd. · Feb 2026
Pump In Style® Pro+
K253498 · Medela, LLC · Jan 2026
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
K253072 · Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. · Dec 2025
Wearable Electric Breast Pump (YM-8803)
K252754 · Guangdong Youmeng Electrical Technology Co., Ltd. · Dec 2025
Spectra Platinum
K251932 · Uzinmedicare Co., Ltd. · Nov 2025
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
K253283 · Shenzhen Root Innovation Technology Co., Ltd. · Oct 2025