Cleared Traditional

K211024 - Electric Breast Pump

K211024 is an FDA 510(k) clearance for Electric Breast Pump, manufactured by Shantou Huihengqi Electronic 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 311-day FDA review.

K211024 · Shantou Huihengqi Electronic Technology Co., Ltd. · Obstetrics & Gynecology device
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Feb 2022
Decision
311d
Days
Class 2
Risk

K211024 is an FDA 510(k) clearance for the Electric Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Shantou Huihengqi Electronic Technology Co., Ltd. (Shantou, CN). The FDA issued a Cleared decision on February 11, 2022 after a review of 311 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Shantou Huihengqi Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K211024

510(k) Number K211024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2021
Decision Date February 11, 2022
Days to Decision 311 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
151d slower than avg
Panel avg: 160d · This submission: 311d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 137
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K211024.
Electric Breast Pump
K212564 · Guangdong Horigen Mother & Baby Products Co., Ltd. · May 2022
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K212773 · Ardo Medical AG · Apr 2022
Fit Pro Breast Pump
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Wearable Breast Pump (Model S12)
K212180 · Shenzhen TPH Technology Co., Ltd. · Feb 2022
Lucy Breast Pump
K213311 · Willow Innovations, Inc. · Feb 2022
Electric breast pump
K212884 · Dongguan Rongfeng Medical Co., Ltd. · Jan 2022