Clearance Summary
Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe received FDA 510(k) clearance under submission number K252814, sponsored by CMT Health PTE., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-02-19.
- Submission: K252814
- Applicant / Sponsor: CMT Health PTE., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2026-02-19
Classification & Regulation
This clearance is catalogued under FDA product code QNQ and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.