Clearance Summary
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) received FDA 510(k) clearance under submission number K261389, sponsored by Salter Labs. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2026-07-30.
- Submission: K261389
- Applicant / Sponsor: Salter Labs
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1720
- Decision date: 2026-07-30
Classification & Regulation
This clearance is catalogued under FDA product code CCL and 21 CFR 868.1720, within the Anesthesiology review panel as a Class II device.