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TK Pre-Filled Normal Saline Flush Syringe

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230756

by Anhui Tiankang Medical Technology Co., Ltd.

Identifiers

510(k) Number
K230756 FDA 510(k)
FDA Product Code
NGT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TK Pre-Filled Normal Saline Flush Syringe is a Vascular Access Flush device designed for administering sterile normal saline solution to maintain or clear vascular access lines. It is classified as a Class II medical device under FDA regulations (21 CFR 880.5200) and is intended for single-use in clinical settings.

This pre-filled syringe is supplied sterile and intended for use in general hospital environments. It is classified as substantially equivalent under a 510(k) clearance (K230756) and adheres to MDR (Medical Device Regulation) standards. The device is non-reusable and must be stored under appropriate conditions to preserve sterility before use.

Frequently asked questions

What is the TK Pre-Filled Normal Saline Flush Syringe used for in clinical settings?

The TK Pre-Filled Normal Saline Flush Syringe is designed specifically for administering sterile normal saline solution to maintain or clear vascular access lines. This helps prevent clotting and ensures the patency of intravenous catheters in general hospital environments.

Is the TK Pre-Filled Normal Saline Flush Syringe intended for single-use or can it be reused?

The device is explicitly labeled for single-use only. Reusing it could compromise sterility and patient safety, so it must be discarded after one use as per manufacturer guidelines.

How should I store the TK Pre-Filled Normal Saline Flush Syringe to maintain sterility before use?

The syringe is supplied sterile, so it must be stored under appropriate conditions to preserve sterility. This typically means keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures, and following the manufacturer’s storage instructions to prevent contamination.

What regulatory pathways does the TK Pre-Filled Normal Saline Flush Syringe follow, and where is it manufactured?

The device follows FDA 510(k) clearance (K230756) and adheres to MDR (Medical Device Regulation) standards. It is manufactured by Anhui Tiankang Medical Technology Co., Ltd. in Tianchang, China.

Are there different sizes or models available for the TK Pre-Filled Normal Saline Flush Syringe?

The provided data lists multiple FEI registration numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the device itself is standardized as a pre-filled saline flush syringe without explicit size variations mentioned in the description. For precise volume or model details, refer to the manufacturer’s packaging or technical documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Anhui Tiankang Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K230756 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026