Cleared Traditional

Spectra S1 Pro; Spectra S2 Pro

K251423 · Uzinmedicare Co., Ltd. · Obstetrics & Gynecology

Feb 2026

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K251423 is an FDA 510(k) clearance for the Spectra S1 Pro; Spectra S2 Pro, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Uzinmedicare Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on February 6, 2026, 274 days after receiving the submission on May 8, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number	K251423 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2025
Decision Date	February 06, 2026
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF