Cleared Traditional

K241680 - Momcozy Wearable Breast Pump (BP311)

K241680 is an FDA 510(k) clearance for Momcozy Wearable Breast Pump (BP311), manufactured by Shenzhen Root Innovation Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K241680 · Shenzhen Root Innovation Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
192d
Days
Class 2
Risk

K241680 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 192 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 Shenzhen Root Innovation Technology Co., Ltd. devices

FDA 510(k) Submission Details - K241680

510(k) Number K241680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2024
Decision Date December 20, 2024
Days to Decision 192 days
Submission Type Traditional
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
32d slower than avg
Panel avg: 160d · This submission: 192d
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

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 135
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K241680.
Ameda GLO Wearable Breast Pump (Model W8S)
K250463 · Shenzhen TPH Technology Co., Ltd. · Mar 2025
Wearable breast pump (model W8)
K242850 · Shenzhen TPH Technology Co., Ltd. · Feb 2025
VIVACE
K242111 · Unimom.Co · Feb 2025
Momcozy Wearable Breast Pump (BP311)
K243629 · Shenzhen Root Innovation Technology Co., Ltd. · Dec 2024
Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
K241322 · Joytech Healthcare Co. , Ltd. · Dec 2024
Electric Breast Pump (F5055)
K240218 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · Oct 2024