Cleared Traditional

Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030) (K203148) - FDA 510(k) Clearance

Also marketed or referenced as:
Bebebao Electric Breast Pump (Model: BB-5020) Yiyadodo Electric Breast Pump (Model: YY-5030)

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

K203148 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
259d
Days
Class 2
Risk

K203148 is an FDA 510(k) clearance for the Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Ningbo Youhe Electrical Appliance Technology Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on July 8, 2021 after a review of 259 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 Ningbo Youhe Electrical Appliance Technology Co., Ltd. devices

Submission Details

510(k) Number K203148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2020
Decision Date July 08, 2021
Days to Decision 259 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
99d slower than avg
Panel avg: 160d · This submission: 259d
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

Shanghai Qisheng Business Consulting Co., Ltd.
Daniel 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 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K203148.
TT Electric Breast Pump, TT Double Electric Breast Pump
K202802 · Wuxi Xinzhongrui Baby Supplies Co., Ltd. · Aug 2021
Elvie Stride
K210936 · Chiaro Technology Limited · Aug 2021
Solo, Swing Maxi
K210759 · Medela, LLC · Aug 2021
Electric Breast Pump
K201152 · Guangdong Horigen Mother & Baby Products Co., Ltd. · May 2021
Mya Joy PLUS Breast Pump
K203570 · Ameda, Inc. · Apr 2021
Electric breast pump (Models: RH-228 and RH-338)
K201903 · Cixi Ruihong Electric Appliance Co., Ltd. · Apr 2021