Cleared Traditional

K192640 - Kidro Digital Electric Breast Pump

K192640 is an FDA 510(k) clearance for Kidro Digital Electric Breast Pump, manufactured by Guangzhou Yongyi Industrial Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K192640 · Guangzhou Yongyi Industrial Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
188d
Days
Class 2
Risk

K192640 is an FDA 510(k) clearance for the Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Guangzhou Yongyi Industrial Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 30, 2020 after a review of 188 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 Guangzhou Yongyi Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K192640

510(k) Number K192640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2019
Decision Date March 30, 2020
Days to Decision 188 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
28d slower than avg
Panel avg: 160d · This submission: 188d
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

Guangzhou Glomed Biologcial Technology Co., Ltd.
Cassie Lee

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 K192640.
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
K193449 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Sep 2020
Pump In Style
K200508 · Medela, LLC · Jun 2020
Rumble Tuff Electric Breast Pump
K200712 · A Cute Baby, Inc. · Apr 2020
Evolve Breast Pump
K200406 · Hygeia II Medical Group, Inc. · Mar 2020
Spectra Q
K191109 · Uzinmedicare Co. · Jan 2020
Electric Breast Pump
K191802 · Ningbo Huiyoo Baby Products Co., Ltd. · Jan 2020