Clearance Summary
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap received FDA 510(k) clearance under submission number K253268, sponsored by CMT Health PTE., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-04-08.
- Submission: K253268
- Applicant / Sponsor: CMT Health PTE., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2026-04-08
Classification & Regulation
This clearance is catalogued under FDA product code PNR and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.