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K-Shield Zen

FDA 510(k)

Class II (US FDA 510(k))

510(k) K220799

by Sb-Kawasumi Laboratories, Inc.

Identifiers

510(k) Number
K220799 FDA 510(k)
FDA Product Code
JKA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1675 FDA 510(k)
Regulation Number
862.1675 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The K-Shield Zen is a needle safety device designed for peripheral venous access, specifically for blood collection. It incorporates a retractable needle mechanism to reduce the risk of needle-stick injuries during use, aligning with safety standards for infusion therapy and phlebotomy procedures. The device is classified under the Clinical Chemistry advisory committee category and is intended for single-use applications in clinical settings.

This device is supplied as a disposable, single-use item and is intended for use in healthcare environments where peripheral blood sampling is required. It is not MRI-compatible and must be handled according to standard aseptic techniques. The K-Shield Zen is authorized under FDA 510K clearance (K220799) and is manufactured by SB-KAWASUMI LABORATORIES, INC. Storage should follow manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

What is the K-Shield Zen designed for?

The K-Shield Zen is specifically designed for peripheral venous access during blood collection procedures. Its retractable needle mechanism helps minimize the risk of needle-stick injuries, making it ideal for phlebotomy and clinical blood sampling where safety is critical.

Is the K-Shield Zen intended for single-use or reuse?

The K-Shield Zen is a disposable, single-use device. It is engineered for one-time clinical use to ensure sterility and safety, preventing cross-contamination and reducing infection risks in healthcare settings.

How should the K-Shield Zen be stored to maintain its integrity?

The K-Shield Zen must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage conditions help ensure the device remains effective for its intended single-use application in clinical environments.

Is the K-Shield Zen compatible with MRI machines?

No, the K-Shield Zen is explicitly stated as not MRI-compatible. This means it should not be used in MRI environments, as the device may interfere with imaging or pose safety risks during the procedure.

What regulatory clearance does the K-Shield Zen hold?

The K-Shield Zen has received FDA 510K clearance under the reference number K220799. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. safety and performance standards for needle safety devices in blood collection.

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. Sources consulted: Kawasumi Laboratories America, Inc., Infusion Therapy | SB-KAWASUMI LABORATORIES, INC., SB-KAWASUMI LABORATORIES, INC. PBM-25G K-SHIELD Zen Winged Blood ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sb-Kawasumi Laboratories, Inc.

Sources (1)

  • FDA 510(k) K220799 24 fields · synced Oct 1, 2026