Cleared Traditional

VIVACE (K232047) - FDA 510(k) Clearance

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

K232047 · Unimom.Co · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
262d
Days
Class 2
Risk

K232047 is an FDA 510(k) clearance for the VIVACE. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Unimom.Co (Osan-Si, KR). The FDA issued a Cleared decision on March 28, 2024 after a review of 262 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 Unimom.Co devices

Submission Details

510(k) Number K232047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2023
Decision Date March 28, 2024
Days to Decision 262 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
102d slower than avg
Panel avg: 160d · This submission: 262d
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

Global Medical Standard Consulting Co., Ltd.
Jong-Hyun Kim

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 K232047.
Electric Breast Pump (BRP-301)
K233913 · Aoj Health Technology Co., Ltd. · May 2024
Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
K232477 · Jiangxi AOV Maternity & Baby Products Co., Ltd. · May 2024
Duo Hands-free Breast Pump
K232608 · Medela, LLC · Apr 2024
Hygeia Express Powered Breast Pump
K233136 · Hygeia II Medical Group, Inc. · Mar 2024
Momcozy Wearable Breast Pump (BP137)
K233880 · Shenzhen Root Innovation Technology Co., Ltd. · Mar 2024
Perifit Pump
K231785 · X6 Innovations · Jan 2024