Cleared Traditional

Electric Breast Pump (F5055) (K240218) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240218 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Oct 2024
Decision
265d
Days
Class 2
Risk

K240218 is an FDA 510(k) clearance for the Electric Breast Pump (F5055). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 17, 2024 after a review of 265 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 Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. devices

Submission Details

510(k) Number K240218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2024
Decision Date October 17, 2024
Days to Decision 265 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
105d slower than avg
Panel avg: 160d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K240218.
Momcozy Wearable Breast Pump (BP311)
K241680 · Shenzhen Root Innovation Technology Co., Ltd. · Dec 2024
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
Elvie Stride 2
K242125 · Chiaro Technology, Ltd. · Sep 2024
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
K241004 · Huizhou Lvb Maternal and Infant Supplies Co., Ltd. · Sep 2024
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
K231969 · Dongguanshi Yiyingmei Technology Co., Ltd. · Aug 2024