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Sterile Disposable Temperature Probe

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K212945

by Shenzhen Envisen Industry Co., Ltd.

Identifiers

510(k) Number
K212945 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

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)

This device is a sterile disposable temperature probe, classified under the nomenclature for single-use thermometry devices. It is designed to measure body temperature accurately and reliably in clinical settings, providing critical patient monitoring data for diagnostic and therapeutic purposes.

The Sterile Disposable Temperature Probe TGMS-1691 and TSMS-1191 is intended for single-use in hospital environments, as indicated by its FDA 510(k) clearance and MDR authorization. Supplied sterile and packaged for one-time use, it adheres to regulatory standards for medical thermometry, ensuring compliance with general hospital protocols. No MRI safety or reusable specifications are noted in the data.

Frequently asked questions

What clinical settings is this temperature probe designed for, and how does its single-use nature benefit patients or facilities?

The Sterile Disposable Temperature Probe (models TGMS-1691 and TSMS-1191) is specifically designed for hospital environments, where accurate and reliable body temperature measurements are critical for patient monitoring. Its single-use, sterile packaging eliminates the risk of cross-contamination between patients, reducing infection risks—a key advantage in clinical settings like emergency rooms, ICUs, or post-operative wards. This aligns with general hospital protocols and ensures compliance with infection control standards.

Are there different models of this probe, and if so, how might they differ in terms of use or specifications?

Yes, there are two models listed: the TGMS-1691 and the TSMS-1191. While the provided data does not specify exact functional differences (e.g., probe design, measurement range, or connection type), the models are both classified under the same FDA 510(k) clearance and MDR authorization for single-use thermometry. Clinicians should refer to the manufacturer’s instructions for model-specific details, such as probe length, tip shape, or compatibility with monitoring systems.

How should this probe be stored, and what precautions should be taken to maintain its sterility before use?

The probe is supplied sterile and packaged for single-use only, so it should be stored in its original, unopened packaging until ready for immediate use. Storage should follow standard hospital protocols for sterile single-use devices—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Once the packaging is opened, the probe must be used immediately to preserve sterility, as it is not designed for reuse or reprocessing.

What regulatory pathways does this device follow, and how does that affect its use in different markets?

This probe has undergone FDA 510(k) clearance (traditional pathway, substantially equivalent to a predicate device) and MDR (Medical Device Regulation) authorization, indicating compliance with both U.S. and EU medical device standards. The FDA 510(k) classification under the General Hospital product code (FLL) confirms its suitability for routine clinical thermometry in hospitals, while the MDR authorization ensures it meets EU requirements for safety and performance. Buyers should verify local regulations, as these approvals may influence market access or labeling requirements.

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: Shenzhen Envisen Industry Co. Ltd, K212945 - Sterile Disposable Temperature Probe - FDA 510 (k), Product Catalogues - Shenzhen Envisen Industry Co. Ltd, Sterile Disposable Temperature Probe (K212945) — FDA 510 (k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Envisen Industry Co., Ltd.

Sources (2)

  • FDA 510(k) K212945 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026