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Infrared Thermometer IR8807

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223037

by Shen Zhen Rong Feng Technology Co., Ltd.

Identifiers

510(k) Number
K223037 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)

The Infrared Thermometer IR8807 is a Clinical Electronic Thermometer designed to measure body temperature non-invasively using infrared technology. It falls under the regulatory classification of FLL (Fever, Low Risk) and operates by detecting thermal radiation emitted from the forehead or ear, providing rapid and contactless temperature readings. This device is intended for use in general hospital settings to assess fever in patients, aiding in initial triage and monitoring.

The IR8807 is supplied as a single-use or reusable device, though specifications do not explicitly state sterility requirements. It is regulated under 21 CFR 880.2910 and received FDA 510(k) clearance (K223037) as substantially equivalent to predicate devices. No MRI safety information or size variations are documented in the available data. Storage conditions are not specified, but typical practice for such devices includes protection from moisture and physical damage.

Frequently asked questions

What is the IR8807 Infrared Thermometer used for?

The IR8807 is designed for clinical use in general hospitals to measure body temperature non-invasively via infrared detection of thermal radiation from the forehead or ear. This aids in quickly identifying fever during patient triage or ongoing monitoring, reducing the need for invasive methods like oral or rectal probes.

Is the IR8807 single-use or reusable?

The IR8807 can be supplied as either single-use or reusable, though the documentation does not specify explicit sterility requirements for either configuration. Reusable units would require proper cleaning and disinfection between uses, while single-use models would follow standard medical device disposal protocols.

What regulatory pathway does the IR8807 follow?

The IR8807 is classified under the FDA’s product code FLL (Fever, Low Risk) and received 510(k) clearance (K223037) as substantially equivalent to predicate devices. This clearance was granted under 21 CFR 880.2910, confirming its compliance for fever screening in clinical settings.

Are there different sizes or models available for the IR8807?

The available data does not mention any size variations or alternative models for the IR8807. All specifications reference the single model number, so users should confirm compatibility with their specific clinical needs before purchase.

How should the IR8807 be stored?

While storage conditions are not explicitly detailed, standard practice for infrared thermometers recommends protecting the device from moisture, physical damage, and extreme temperatures. Store in a clean, dry environment away from direct sunlight or sources of electromagnetic interference to maintain accuracy and functionality.

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: Infrared Thermometer, Model: IR8807 (K223037) — FDA 510 (k) | Innolitics, K223037 - Infrared Thermometer, Model: IR8807 - FDA 510 (k), Infrared Thermometer, Model: IR8807 — FDA K223037, Infrared Thermometer, Model: IR8807 510(k) K223037 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shen Zhen Rong Feng Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K223037 24 fields · synced Oct 1, 2026