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Oral/Enteral Syringe with ENFit Connector

by Ningbo Tianyi Medical Appliance CO., Ltd.

510(k) K211025

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211025↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211025 Date30 Jun 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PNR
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Enteral Syringe with Enteral Specific Connectors, designed for the administration of liquids via oral or enteral routes. It features an ENFit connector, a standardized interface for safe and secure attachment to enteral feeding tubes, reducing the risk of misconnections and contamination.

The syringe is supplied as a single-use, non-sterile medical device, intended for use in clinical settings such as gastroenterology and urology. It is classified as a Class II device under FDA regulations (21 CFR 876.5980) and has received FDA 510(k) clearance and MDR authorization. Multiple model references are listed for regulatory tracking, including FEI numbers such as 3013557562 and others, but no specific storage conditions are detailed beyond standard medical device handling.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of this syringe, and in which clinical settings is it typically used?

    This syringe is designed specifically for the administration of liquids via oral or enteral routes, featuring an ENFit connector to ensure safe and secure attachment to enteral feeding tubes. It reduces the risk of misconnections and contamination, making it ideal for clinical settings like gastroenterology and urology, where precise liquid delivery is critical.

  • Is this syringe meant for single-use or repeated use, and what does that mean for clinical workflows?

    The syringe is intended for single-use only, meaning it should not be reused after one administration. This design choice helps minimize infection risks and ensures patient safety, which is particularly important in sterile environments like hospitals or clinics where enteral feeding is performed.

  • Are there different sizes or models available for this syringe, and how would I identify the correct one for my needs?

    While the exact sizes or model specifications aren’t detailed in the provided data, the device includes multiple FEI numbers (e.g., 3013557562, 3010331226, etc.) for regulatory tracking, which may correspond to different variants or configurations. For precise sizing or model selection, refer to the manufacturer’s catalog or consult their technical support, as these details are essential for compatibility with feeding tubes and patient-specific requirements.

  • How should this syringe be stored, and are there any special handling instructions beyond standard medical device protocols?

    The data does not specify unique storage conditions beyond general medical device handling. However, as a non-sterile single-use device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow facility protocols for sterile field preparation when using it in clinical settings to maintain hygiene and safety.

  • What regulatory pathways has this device undergone, and how does that affect its use in clinical practice?

    This syringe has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and performance. The Class II designation (21 CFR 876.5980) indicates it undergoes additional scrutiny but is not classified as high-risk. Clinicians can rely on its compliance with these pathways, though local institutional policies should still be followed for procurement and use.