Infrared Ear Therometer

FDA 510(k) K111703 · Fudakang Industrial Co., Ltd.

Substantially Equivalent

510(k) numberK111703

Submission

Device name
Infrared Ear Therometer
Applicant
Fudakang Industrial Co., Ltd.
Buena Park, CA, US
Received
June 17, 2011
Decision date
March 29, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FLL – Continuous Measurement Thermometer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2910
Specialty
General Hospital

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Other 510(k)s with product code FLL

510(k)DeviceApplicantDecision
K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional Unimed Medical Supplies, Inc.06/05/2026SE
K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…FLL · Traditional Shenzhen Med-Link Electronics Tech Co., Ltd.01/08/2026SE
K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)FLL · Traditional Shenzhen AOJ Medical Technology Co., Ltd.06/23/2025SE
K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe…FLL · Traditional Shenzhen Medke Technology Co., Ltd.06/20/2025SE
K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)FLL · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.05/22/2025SE
K243082Infrared ThermometerFLL · Traditional Guangzhou Daxin Health Technology Co., Ltd.04/25/2025SE
K250401AION TempShield™FLL · Traditional Aion Biosystems, Inc.03/14/2025SE
K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…FLL · Traditional Shenzhen Finicare Co., Ltd.02/14/2025SE
K240333Wearable Digital Thermometer (T31)FLL · Traditional Guangdong Genial Technology Co., Ltd.10/30/2024SE
K240223FMT Disposable and Autoclavable Temperature ProbesFLL · Traditional Metko Medikal VE Tibbi Cihazlar Dis Ticaret…10/25/2024SE

More from Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi

510(k)DeviceDecision
K172121Digital ThermometerFLL · Traditional 06/07/2018SE
K160308Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)FLL · Special 07/15/2016SE
K150430Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorDXN · Traditional 04/17/2015SE

Questions and answers

When was Infrared Ear Therometer cleared by the FDA?

Infrared Ear Therometer (K111703) received a 510(k) decision of Substantially Equivalent on March 29, 2012, 286 days after the submission was received.

What is the product code of K111703?

The FDA product code is FLL – Continuous Measurement Thermometer, a Class II (moderate risk) device regulated under 21 CFR 880.2910.