Oral/Enteral Syringe with ENFit connector

FDA 510(k) K211025 · Ningbo Tianyi Medical Appliance Co., Ltd.

Substantially Equivalent

510(k) numberK211025

Submission

Device name
Oral/Enteral Syringe with ENFit connector
Applicant
Ningbo Tianyi Medical Appliance Co., Ltd.
Ningbo, CN
Received
April 6, 2021
Decision date
June 30, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PNR – Enteral Syringes With Enteral Specific Connectors
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.

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K252483Enteral Syringe (20ml, 60ml)PNR · Traditional Chirana T.Injecta,A.S.07/01/2026SE
K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe…PNR · Traditional CMT Health PTE., Ltd.04/08/2026SE
K251585Profoject™ Enteral Feeding SyringePNR · Traditional CMT Health PTE., Ltd.07/18/2025SE
K243652Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with…PNR · Special Cardinalhealth12/19/2024SE
K231300Nutricair Enteral Syringe with ENFitPNR · Traditional Cair Lgl10/06/2023SE
K222772Oral/Enteral Syringe with ENFit connectorPNR · Traditional Anhui Tiankang Medical Technology Co., Ltd.08/17/2023SE
K211661ENFit enteral syringes (NUTRIFIT)PNR · Traditional Pentaferte Italia S.R.L.02/28/2022SE
K211593Enteral Pump SyringePNR · Traditional Jiangsu Caina Medical Co.,Ltd09/30/2021SE
K203613ENFit Reusable Enteral SyringePNR · Traditional Shantou Wealy Medical Instrument Co.,Ltd08/27/2021SE
K203410ENFit Disposable Enteral SyringePNR · Traditional Shantou Wealy Medical Instrument Co.,Ltd06/28/2021SE

More from Shantou Wealy Medical Instrument Co.,Ltd

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K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)FJK · Traditional 10/02/2025SE
K210621Oral/Enteral SyringePNR · Traditional 04/28/2021SE

Questions and answers

When was Oral/Enteral Syringe with ENFit connector cleared by the FDA?

Oral/Enteral Syringe with ENFit connector (K211025) received a 510(k) decision of Substantially Equivalent on June 30, 2021, 85 days after the submission was received.

What is the product code of K211025?

The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.