Clearance Summary
SPECTRA Wearable 2 received FDA 510(k) clearance under submission number K250208, sponsored by Uzinmedicare Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2026-04-06.
- Submission: K250208
- Applicant / Sponsor: Uzinmedicare Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2026-04-06
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.