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Sterile temperature probe - W0099FS

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K251160

by Shenzhen Med-Link Electronics Tech Co., Ltd.

Identifiers

510(k) Number
K251160 FDA 510(k)
FDA Product Code
FLL FDA 510(k)
Models / Variants
Model: W0001ES FDA 510(k)EUDAMED
W0028ES FDA 510(k)EUDAMED
W0101FS-A FDA 510(k)EUDAMED
W0101FS-P FDA 510(k)EUDAMED
W0099LS FDA 510(k)EUDAMED
W0099FS FDA 510(k)EUDAMED
W0099PS FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sterile Temperature Probe is a disposable medical device designed for accurate measurement of temperature in clinical settings. It falls under the category of a temperature-measuring probe, intended for use in monitoring physiological temperatures, such as body or environmental temperatures in healthcare environments.

These probes are supplied sterile and intended for single-use, ensuring patient safety and hygiene. They are classified as FDA Class II devices and comply with both FDA 510(k) clearance and EU MDR regulations. The models vary in specifications but are generally used in general hospital settings for precise temperature readings, with no indication of MRI compatibility or reusable variants.

Frequently asked questions

Are these temperature probes reusable or intended for single-use, and why does that matter in a clinical setting?

These probes are explicitly designed for single-use only, as stated in the description. This ensures patient safety and hygiene, reducing the risk of cross-contamination between patients. Single-use devices are also easier to sterilize and maintain in compliance with infection control protocols, which is critical in clinical environments where precision and sterility are paramount.

What models are available, and how do I determine which one might be best suited for my hospital’s needs?

The available models include W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, and W0099PS. While the exact specifications (e.g., probe length, connector type, or temperature range) aren’t detailed here, the models are categorized under FDA product code FLL for general hospital use. To choose the right one, consult the manufacturer’s technical specifications or contact their support team, as variations may exist in probe design or compatibility with monitoring systems.

How should these sterile temperature probes be stored before use, and what precautions should be taken?

Since these probes are sterile and single-use, they should be stored in their original, sealed packaging until ready for use. The packaging likely includes protective barriers to maintain sterility. Store them in a clean, dry environment away from direct sunlight or extreme temperatures, as exposure to contaminants or environmental factors could compromise sterility. Always follow the manufacturer’s storage instructions to ensure reliability and safety.

What regulatory pathways have these probes undergone, and how does that affect their use in healthcare settings?

These probes have undergone FDA 510(k) clearance (traditional pathway, substantially equivalent) and comply with EU MDR regulations. This means they meet U.S. and European safety and performance standards for temperature measurement in clinical settings. The FDA classification as Class II indicates they require more oversight than Class I devices but are not as stringent as Class III. Clinicians can trust these probes for accurate physiological temperature monitoring in general hospital environments.

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: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS ..., Sterile Temperature Probe - Medical Device Navigator, Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Med-Link Electronics Tech Co., Ltd.

Sources (2)

  • FDA 510(k) K251160 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026