K253268
Substantially EquivalentProfoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
The Profoject Enteral/Oral Feeding Syringe line is a set of ENFit-compliant feeding syringes and accessories. Product code PNR covers enteral feeding systems; the filing bundles single-use and reusable variants, an adaptor, and caps into a single clearance.
Gastroenterology, Urology panel, Traditional 510(k). ENFit connectors became the standard for enteral feeding after the misconnection-related patient-safety initiatives of the last decade; PNR filings routinely cover ENFit-specific syringe configurations.
CMT Health PTE. files from Singapore. Six-month review clock. Multi-SKU clearances in a single 510(k) are standard practice for this category — grouping product variants reduces filing overhead.
- Applicant
- CMT Health PTE., Ltd.
- Product code
- PNR
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
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.