Profoject Enteral/Oral Feeding Syringe +3 more— 510(k) K253268
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K253268 for Profoject Enteral/Oral Feeding Syringe +3 more, Substantially Equivalent on 2026-04-08. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Summary
The Profoject line covers enteral and oral feeding syringes in single-use and reusable versions, plus an ENFit adaptor and syringe caps. Product code PNR is for enteral syringes with enteral-specific connectors, used to deliver nutrition, medication, or hydration orally or to a gastrointestinal tube.
Class II, 21 CFR 876.5980. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
CMT Health filed from Singapore. Review took 191 days (September 29, 2025 to April 8, 2026).
Clearance details
- Device name as filed
- Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
- Applicant
- CMT Health PTE., Ltd.
- Product code
- Product code PNR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code PNR
view allMore clearances from CMT Health PTE., Ltd.
view allAdverse events under product code PNR
product code PNR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.