Cleared Traditional

K223329 - Electric Breast Pump (model: YY-A46

K223329 is an FDA 510(k) clearance for Electric Breast Pump (model: YY-A46, manufactured by Guangzhou Yongyi Industrial Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K223329 · Guangzhou Yongyi Industrial Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
207d
Days
Class 2
Risk

K223329 is an FDA 510(k) clearance for the Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Guangzhou Yongyi Industrial Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 26, 2023 after a review of 207 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 Guangzhou Yongyi Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K223329

510(k) Number K223329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2022
Decision Date May 26, 2023
Days to Decision 207 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
47d slower than avg
Panel avg: 160d · This submission: 207d
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

Guangzhou Glomed Biologcial Technology Co., Ltd.
Cassie Lee

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 K223329.
Wearable Breast Pump (Model S18)
K223886 · Shenzhen TPH Technology Co., Ltd. · Jul 2023
Compact Wearable Pump
K230469 · Lansinoh Laboratories · Jun 2023
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
K230776 · Shenzhen Lutejiacheng Technology Co., Ltd. · Jun 2023
ARDO Bellis
K230590 · Ardo Medical AG · Mar 2023
MilkMate Breast Pump
K223084 · Milkmate Products, Inc. · Mar 2023
Electric breast pump (model: M5)
K223693 · Shenzhen Lutejiacheng Technology Co., Ltd. · Mar 2023