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Fora IR22 Ear Thermometer, Model TD-1262

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090294

by Taidoc Technology Corporation

Identifiers

510(k) Number
K090294 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 Fora IR22 Ear Thermometer, Model TD-1262 is an electronic clinical thermometer designed to measure body temperature via infrared technology. It detects thermal radiation emitted from the ear canal, providing rapid and non-contact readings for clinical or home use. This device falls under the classification of thermometers, electronic, clinical as defined by regulatory nomenclature.

This single-use device is intended for use in general hospital settings and is approved for home patient use across all age groups. Supplied sterile and packaged individually, it requires no special storage conditions beyond protection from physical damage. The device holds FDA 510(k) clearance (K090294) under Regulation 880.2910, classified as Class II with a Special 510(k) review and a Substantially Equivalent (SESE) determination.

Frequently asked questions

Is the Fora IR22 Ear Thermometer reusable or single-use, and how does that affect its use in clinical settings?

The Fora IR22 Ear Thermometer (Model TD-1262) is designed as a single-use device, supplied sterile and packaged individually. This ensures infection control compliance in clinical settings like hospitals, where reuse could pose risks. The sterile packaging also simplifies single-patient use, reducing cross-contamination concerns without requiring reprocessing.

What storage requirements does the Fora IR22 Ear Thermometer have, and can it be stored in standard hospital environments?

The device requires no special storage conditions beyond protection from physical damage. It can be stored in standard hospital environments or at home, as long as the packaging remains intact until use. This makes it convenient for both clinical and home settings without requiring refrigeration or controlled environments.

What age groups is the Fora IR22 Ear Thermometer approved for, and how does its infrared technology differ from traditional ear thermometers?

The Fora IR22 is approved for use across all age groups, from infants to adults, in both hospital and home settings. Unlike traditional ear thermometers that may require probe insertion, this model uses infrared technology to detect thermal radiation from the ear canal without physical contact, enabling faster, non-invasive readings while maintaining accuracy.

How is the Fora IR22 Ear Thermometer regulated, and what does its FDA clearance classification mean for buyers?

The device holds FDA 510(k) clearance (K090294) under Regulation 880.2910, classified as Class II with a Special 510(k) review and a Substantially Equivalent (SESE) determination. This means it meets FDA standards for safety and effectiveness comparable to legally marketed predecessors, ensuring compliance for clinical use in hospitals and patient homes.

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: FORA IR22 EAR THERMOMETER, MODEL TD-1262 (K090294) — FDA 510 (k ..., FORA IR22 EAR THERMOMETER, MODEL TD-1262 - beudamed.com, FORA IR22 EAR THERMOMETER, MODEL TD-1262 510(k) K090294 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taidoc Technology Corporation

Sources (1)

  • FDA 510(k) K090294 24 fields · synced Sep 19, 2026