Cleared Traditional

K253946 - 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) (FDA 510(k) Clearance)

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

K253946 · Shenzhen Root Innovation Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
118d
Days
Class 2
Risk

K253946 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D,.... Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Shenzhen Root Innovation Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 7, 2026 after a review of 118 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 Shenzhen Root Innovation Technology Co., Ltd. devices

Submission Details

510(k) Number K253946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2025
Decision Date April 07, 2026
Days to Decision 118 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
42d faster than avg
Panel avg: 160d · This submission: 118d
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 Peers - HGX Pump, Breast, Powered

All 234
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K253946.
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
SPECTRA Wearable 2
K250208 · Uzinmedicare Co., Ltd. · Apr 2026