Cleared Traditional

K251977 - electric breast pump (FZ-P8)

Also marketed or referenced as:
electric breast pump (YH-P8) electric breast pump (YH-P8X)

K251977 is an FDA 510(k) clearance for electric breast pump (FZ-P8), manufactured by Ningbo Youhe Electrical Appliance 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 117-day FDA review.

K251977 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
117d
Days
Class 2
Risk

K251977 is an FDA 510(k) clearance for the electric breast pump (FZ-P8). 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 October 22, 2025 after a review of 117 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 Ningbo Youhe Electrical Appliance Technology Co., Ltd. devices

FDA 510(k) Submission Details - K251977

510(k) Number K251977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2025
Decision Date October 22, 2025
Days to Decision 117 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
43d faster than avg
Panel avg: 160d · This submission: 117d
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

Huaxiajiamei (Beijing) Information Consulting Co.,Ltd
Linda Li

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 136
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K251977.
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
K253283 · Shenzhen Root Innovation Technology Co., Ltd. · Oct 2025
Electric Breast Pump (HL-3058, F5112)
K252629 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · Oct 2025
Electric Breast Pump (HL-3060, F5113)
K252630 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · Oct 2025
Hi bebe super (BT-150B)
K251512 · Bistos Co., Ltd. · Sep 2025
Magic InBra
K251377 · Medela AG · Sep 2025
Momcozy Wearable Breast Pump (BP223)
K251394 · Shenzhen Root Innovation Technology Co., Ltd. · Sep 2025