Cleared Traditional

K260538 - Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )

K260538 is an FDA 510(k) clearance for Momcozy Wearable Breast Pump (BP420, 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 120-day FDA review.

K260538 · Shenzhen Root Innovation Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
120d
Days
Class 2
Risk

K260538 is an FDA 510(k) clearance for the Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-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 June 17, 2026 after a review of 120 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

FDA 510(k) Submission Details - K260538

510(k) Number K260538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2026
Decision Date June 17, 2026
Days to Decision 120 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
41d faster than avg
Panel avg: 161d · This submission: 120d
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 Peers - HGX Pump, Breast, Powered

All 227
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K260538.
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
K250070 · Shenzhen Changkun Technology Co., Ltd. · Jun 2026
Wearable breast pump (QY-101, QY-102, QY-108)
K261025 · Shenzhen Qinyi Electronic Technology Co., Ltd. · Jun 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
K254254 · Shenzhen Root Innovation Technology Co., Ltd. · Jun 2026
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
K260346 · Polybell (Guangzhou) Limited · Jun 2026
AViTA Breast Pump
K250129 · Avita Corporation · Jun 2026
Mother's Nature W1 Warming Wearable Breast Pump
K260864 · Shenzhen TPH Technology Co., Ltd. · Jun 2026