Cleared Traditional

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) (K193449) - FDA 510(k) Clearance

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

K193449 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Obstetrics & Gynecology device
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Sep 2020
Decision
273d
Days
Class 2
Risk

K193449 is an FDA 510(k) clearance for the Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP0.... Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Guangdong Horigen Mother & Baby Products Co., Ltd. (Shantou, CN). The FDA issued a Cleared decision on September 11, 2020 after a review of 273 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 Guangdong Horigen Mother & Baby Products Co., Ltd. devices

Submission Details

510(k) Number K193449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2019
Decision Date September 11, 2020
Days to Decision 273 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
113d slower than avg
Panel avg: 160d · This submission: 273d
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

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