Cleared Traditional

K163183 - Yooeehouse Breast Pump

K163183 is an FDA 510(k) clearance for Yooeehouse Breast Pump, manufactured by Nantong Poly 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 322-day FDA review.

K163183 · Nantong Poly Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
322d
Days
Class 2
Risk

K163183 is an FDA 510(k) clearance for the Yooeehouse Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Nantong Poly Technology Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on October 2, 2017 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nantong Poly Technology Co., Ltd. devices

FDA 510(k) Submission Details - K163183

510(k) Number K163183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date October 02, 2017
Days to Decision 322 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
162d slower than avg
Panel avg: 160d · This submission: 322d
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

Medwheat (Shanghai) Medical Technology Co. , Ltd.
Jonathan Hu

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 204
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K163183.
Electric Breast Pump
K172989 · Joytech Healthcare Co. , Ltd. · Dec 2017
One Mum Pumpset
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Freemie Independence, Freemie Liberty
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Moxxly Flow Collection System
K170722 · Moxxly, Inc. · Aug 2017
Youha electric breast pump
K163136 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Jul 2017
Spectra 9Plus
K162415 · Uzinmedicare Company · Mar 2017