Cleared Special

K253283 - Momcozy Wearable Breast Pump (Model: BP334-

K253283 is an FDA 510(k) clearance for Momcozy Wearable Breast Pump (Model: BP334-, manufactured by Shenzhen Root Innovation Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 30-day FDA review.

K253283 · Shenzhen Root Innovation Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
30d
Days
Class 2
Risk

K253283 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, .... 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 October 29, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen Root Innovation Technology Co., Ltd. devices

FDA 510(k) Submission Details - K253283

510(k) Number K253283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date October 29, 2025
Days to Decision 30 days
Submission Type Special
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
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Peers - HGX Pump, Breast, Powered

All 135
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K253283.
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
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