FDA Product Code PNR: Enteral Syringes With Enteral Specific Connectors
Safe enteral nutrition delivery requires connectors that cannot be accidentally connected to intravenous lines. FDA product code PNR covers enteral syringes with enteral-specific connectors.
These syringes use ENFit or other enteral-specific connector designs that are physically incompatible with IV Luer connectors, preventing the catastrophic error of accidentally injecting enteral formula into the bloodstream.
PNR devices are Class II medical devices, regulated under 21 CFR 876.5980 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Jiangsu Caina Medical Co.,Ltd, CMT Health PTE., Ltd. and Anhui Tiankang Medical Technology Co., Ltd..
FDA 510(k) Cleared Enteral Syringes With Enteral Specific Connectors Devices (Product Code PNR)
About Product Code PNR - Regulatory Context
510(k) Submission Activity
34 total 510(k) submissions under product code PNR since 2015, with 34 receiving FDA clearance (average review time: 158 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under PNR have taken an average of 90 days to reach a decision - down from 164 days historically, suggesting improved FDA processing for this classification.
PNR devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →