Cleared Traditional

K232466 - Electric Breast Pump

K232466 is an FDA 510(k) clearance for Electric Breast Pump, 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 157-day FDA review.

K232466 · Guangdong Youmeng Electrical Technology Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 2024
Decision
157d
Days
Class 2
Risk

K232466 is an FDA 510(k) clearance for the Electric Breast Pump, model: YM-8166. 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 January 19, 2024 after a review of 157 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 Guangdong Youmeng Electrical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K232466

510(k) Number K232466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2023
Decision Date January 19, 2024
Days to Decision 157 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
3d faster than avg
Panel avg: 160d · This submission: 157d
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

Feiying Drug & Medical Consulting Technical Service Group
Candice Qiu

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 K232466.
Hygeia Express Powered Breast Pump
K233136 · Hygeia II Medical Group, Inc. · Mar 2024
Momcozy Wearable Breast Pump (BP137)
K233880 · Shenzhen Root Innovation Technology Co., Ltd. · Mar 2024
Perifit Pump
K231785 · X6 Innovations · Jan 2024
Evenflo Premium Double Electric Breast Pump (Model 4018)
K230481 · Evenflo Feeding, Inc. · Nov 2023
Electric Breast Pump
K231595 · Shenzhen Changkun Technology Co., Ltd. · Oct 2023
Willow Generation 3 Breast Pump
K230570 · Willow Innovations, Inc. · Oct 2023