Cleared Special

K243629 - Momcozy Wearable Breast Pump (BP311) (FDA 510(k) Clearance)

Also includes:

Momcozy Wearable Breast Pump (BP223) Momcozy Wearable Breast Pump (BP324) Momcozy Wearable Breast Pump (BP334) Momcozy Wearable Breast Pump (BP430)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243629 · Shenzhen Root Innovation Technology Co., Ltd. · Obstetrics & Gynecology device

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Dec 2024

Decision

25d

Days

Class 2

Risk

K243629 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (BP311). 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 December 20, 2024 after a review of 25 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

Submission Details

510(k) Number	K243629 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 25, 2024
Decision Date	December 20, 2024
Days to Decision	25 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

135d faster than avg

Panel avg: 160d · This submission: 25d

Pathway characteristics

Modification to existing cleared device.

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

Shenzhen Root Innovation Technology Co., , Ltd.

Amy Dong

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.