Cleared Traditional

VIVACE (K242111) - FDA 510(k) Clearance

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

K242111 · Unimom.Co · Obstetrics & Gynecology device
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Feb 2025
Decision
202d
Days
Class 2
Risk

K242111 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 February 6, 2025 after a review of 202 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.

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Submission Details

510(k) Number K242111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2024
Decision Date February 06, 2025
Days to Decision 202 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
42d slower than avg
Panel avg: 160d · This submission: 202d
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
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K242111.
eufy Wearable Breast Pump S1 (T8D02) Model T8D02
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Ameda GLO Wearable Breast Pump (Model W8S)
K250463 · Shenzhen TPH Technology Co., Ltd. · Mar 2025
Wearable breast pump (model W8)
K242850 · Shenzhen TPH Technology Co., Ltd. · Feb 2025
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