Cleared Traditional

K250070 - Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

K250070 is an FDA 510(k) clearance for Electric breast pump (MY-375, manufactured by Shenzhen Changkun 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 532-day FDA review.

K250070 · Shenzhen Changkun Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
532d
Days
Class 2
Risk

K250070 is an FDA 510(k) clearance for the Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Shenzhen Changkun Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 26, 2026 after a review of 532 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Shenzhen Changkun Technology Co., Ltd. devices

FDA 510(k) Submission Details - K250070

510(k) Number K250070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2025
Decision Date June 26, 2026
Days to Decision 532 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
371d slower than avg
Panel avg: 161d · This submission: 532d
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

Shenzhen Reanny Medical Devices Mgmt Consulting Co., Ltd.
Reanny 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 227
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K250070.
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
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K260538 · Shenzhen Root Innovation Technology Co., Ltd. · Jun 2026