PNRClass II

Enteral Syringes With Enteral Specific Connectors

21 CFR 876.5980 / Gastroenterology, Urology

PNR is the FDA product code for Enteral Syringes With Enteral Specific Connectors, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors". As of 2026-09-10, FDA records hold 34 510(k) clearances under this code, the most recent dated 2026-07-01, and 4 recalls.

Classification record

Product code: PNR
Device name: Enteral Syringes With Enteral Specific Connectors
FDA definition: Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Regulation: 21 CFR 876.5980
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 34
Ingested recalls: 4

Clearances, product code PNR

By decision year

34 clearances under product code PNR with a decision year between 2015 and 2026, 2016 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code PNR by decision year
Year	Clearances
2015	3
2016	6
2017	5
2018	3
2019	2
2020	3
2021	5
2022	1
2023	2
2024	1
2025	1
2026	2

Applicants with the most clearances

Product code PNR

Applicants holding the most 510(k) clearances under product code PNR
Applicant	Clearances
Medtronic, Inc.	4
Halyard Health	4
CMT Health Pte. Ltd.	2
Jiangsu Caina Medical Co., Ltd	2
Ningbo Tianyi Medical Appliance CO., Ltd.	2
Pentaferte Italia S.r.l.	2
Shantou Wealy Medical Instrument Co., Ltd.	2
Amsino International, Inc.	1
Anhui Tiankang Medical Technology Co., Ltd.	1
Cair LGL	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order