Cleared Traditional

Electric breast pump (Models: RH-228 and RH-338) (K201903) - FDA 510(k) Clearance

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

K201903 · Cixi Ruihong Electric Appliance Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 2021
Decision
275d
Days
Class 2
Risk

K201903 is an FDA 510(k) clearance for the Electric breast pump (Models: RH-228 and RH-338). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Cixi Ruihong Electric Appliance Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on April 9, 2021 after a review of 275 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 Cixi Ruihong Electric Appliance Co., Ltd. devices

Submission Details

510(k) Number K201903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2020
Decision Date April 09, 2021
Days to Decision 275 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
115d slower than avg
Panel avg: 160d · This submission: 275d
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 Peers - HGX Pump, Breast, Powered

All 127
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