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. ENFit is the connector standard designed to stop feeding lines from being hooked up to IV lines by mistake.
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
- 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 all- K261829 — Profoject Dual-Safety Pen Needles
- K260739 — Profoject Pen Needles (Model A; Model B)
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
- K260855 — Profoject Safety Pen Needles
- K253068 — Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
Adverse 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.