Cleared Traditional

K202802 - TT Electric Breast Pump, TT Double Electric Breast Pump (FDA 510(k) Clearance)

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

K202802 · Wuxi Xinzhongrui Baby Supplies Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
337d
Days
Class 2
Risk

K202802 is an FDA 510(k) clearance for the TT Electric Breast Pump, TT Double Electric Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Wuxi Xinzhongrui Baby Supplies Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 26, 2021 after a review of 337 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 Wuxi Xinzhongrui Baby Supplies Co., Ltd. devices

Submission Details

510(k) Number K202802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2020
Decision Date August 26, 2021
Days to Decision 337 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
177d slower than avg
Panel avg: 160d · This submission: 337d
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 Landlink Medical Information Technology Co., Ltd.
Shelley 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 234
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K202802.
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
K253914 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
K260239 · Jiangxi AOV Maternity & Baby Products Co., Ltd. · Apr 2026
Freestyle Mini Hands-free
K253510 · Medela, LLC · Apr 2026
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
K254258 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026
Wearable Breast Pump (Model S21A)
K260033 · Shenzhen TPH Technology Co., Ltd. · Apr 2026
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
K253946 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026