Cleared Traditional

Spectra Platinum (K251932) - FDA 510(k) Clearance

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

K251932 · Uzinmedicare Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 2025
Decision
154d
Days
Class 2
Risk

K251932 is an FDA 510(k) clearance for the Spectra Platinum. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Uzinmedicare Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on November 25, 2025 after a review of 154 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 Uzinmedicare Co., Ltd. devices

Submission Details

510(k) Number K251932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2025
Decision Date November 25, 2025
Days to Decision 154 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
6d faster than avg
Panel avg: 160d · This submission: 154d
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 K251932.
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
K253072 · Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. · Dec 2025
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
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Wearable Electric Breast Pump (YM-8803)
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Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
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Electric Breast Pump (HL-3058, F5112)
K252629 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · Oct 2025
Electric Breast Pump (HL-3060, F5113)
K252630 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · Oct 2025