Cleared Traditional

K223693 - Electric breast pump (model: M5)

K223693 is an FDA 510(k) clearance for Electric breast pump (model: M5), manufactured by Shenzhen Lutejiacheng 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 90-day FDA review.

K223693 · Shenzhen Lutejiacheng Technology Co., Ltd. · Obstetrics & Gynecology device
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Mar 2023
Decision
90d
Days
Class 2
Risk

K223693 is an FDA 510(k) clearance for the Electric breast pump (model: M5). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Shenzhen Lutejiacheng Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 9, 2023 after a review of 90 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 Lutejiacheng Technology Co., Ltd. devices

FDA 510(k) Submission Details - K223693

510(k) Number K223693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2022
Decision Date March 09, 2023
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 Management Consulting Co., L
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 136
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K223693.
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
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