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BladeFlask Universal

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K213274

by Qlicksmart Pty Ltd

Identifiers

510(k) Number
K213274 FDA 510(k)
FDA Product Code
MMK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BladeFlask Universal is a container for sharps, designed to safely collect and dispose of used blades and other sharp medical instruments. It provides a secure, puncture-resistant enclosure to minimise the risk of needlestick injuries and contamination during clinical procedures.

This device is intended for single-use in general hospital settings and is classified as a Class II medical device. Supplied sterile, it requires no special storage conditions beyond a clean, dry environment. The BladeFlask Universal is authorised under FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for sharps containment.

Frequently asked questions

What types of sharps can the BladeFlask Universal safely contain, and is it suitable for use in all general hospital settings?

The BladeFlask Universal is designed to securely collect and dispose of used blades and other sharp medical instruments, such as scalpels, needles, and similar devices. It is specifically authorized for single-use in general hospital settings, as indicated by its classification as a Class II medical device and its regulatory submissions under the General Hospital advisory committee. This makes it suitable for routine clinical procedures where sharps disposal is required.

How should the BladeFlask Universal be stored before use, and does it require any special handling?

The BladeFlask Universal is supplied sterile and only requires storage in a clean, dry environment. No additional sterilization or special handling is necessary before use, as it is intended for single-use and comes pre-sterilized. This ensures convenience and reduces the risk of contamination prior to deployment in clinical settings.

Is the BladeFlask Universal reusable, or is it intended for single-use only? How does this affect its disposal?

The BladeFlask Universal is explicitly designed for single-use only, as stated in its description. This means it should not be reused after disposal of sharps, which simplifies compliance with infection control protocols and reduces the risk of cross-contamination. After use, it should be disposed of according to local sharps disposal guidelines.

What regulatory pathways does the BladeFlask Universal follow, and how does this ensure its compliance with safety standards?

The BladeFlask Universal is authorized through both FDA 510K clearance and MDR (Medical Device Regulation) compliance, ensuring it meets stringent regulatory standards for safety and effectiveness. The device is classified as substantially equivalent under the FDA’s abbreviated clearance process, and its MDR compliance confirms adherence to European Union safety requirements. This dual authorization supports its use in both U.S. and international healthcare settings.

Are there different sizes or models of the BladeFlask Universal, or is it available in a single configuration?

The provided data does not specify multiple sizes or models for the BladeFlask Universal. It is described as a universal container for sharps, implying a standardized design for general hospital use. If specific sizing or customization is required, it would be best to confirm directly with Qlicksmart Pty Ltd, as the details are not explicitly outlined in the regulatory submissions.

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
Qlicksmart Pty Ltd
FDA Applicant
Qlicksmart Pty , Ltd.

Sources (2)

  • FDA 510(k) K213274 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026