PNR
- Product code
- PNR
- Device name
- Enteral Syringes With Enteral Specific Connectors
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 34 (all years; only the last 3 years are listed here)
FDA classification definition
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252483 | 2026-07-01 | Chirana T.Injecta,A.S. | Enteral Syringe (20ml, 60ml) | |
| K253268 | 2026-04-08 | CMT Health PTE., Ltd. | Profoject Enteral/Oral Feeding Syringe; Profoject Re… | FDA |
| K251585 | 2025-07-18 | CMT Health PTE., Ltd. | Profoject Enteral Feeding Syringe | |
| K243652 | 2024-12-19 | Cardinalhealth | Monoject Enteral Syringe with ENFit Connector (401S… | — |
| K231300 | 2023-10-06 | Cair Lgl | Nutricair Enteral Syringe with ENFit |
Official FDA classification page: PNR
Classification and pathway per current FDA publications. Data from openFDA (CC0).