PNR

Enteral Syringes With Enteral Specific Connectors

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-07-01.

NumberDecision dateApplicantDevice nameSummary
K2524832026-07-01Chirana T.Injecta,A.S.Enteral Syringe (20ml, 60ml)PDF
K2532682026-04-08CMT Health PTE., Ltd.Profoject Enteral/Oral Feeding Syringe; Profoject Re…FDA
K2515852025-07-18CMT Health PTE., Ltd.Profoject™ Enteral Feeding SyringePDF
K2436522024-12-19CardinalhealthMonoject™ Enteral Syringe with ENFit Connector (401S…
K2313002023-10-06Cair LglNutricair Enteral Syringe with ENFitPDF

3 summaries are archived here for direct download.

Official FDA classification page: PNR
Classification and pathway per current FDA publications. Data from openFDA (CC0).