Infrared thermometer

FDA 510(k) K221211 · Shenzhen Yolanda Technology Co., Ltd.

Substantially Equivalent

510(k) numberK221211

Submission

Device name
Infrared thermometer
Applicant
Shenzhen Yolanda Technology Co., Ltd.
Shenzhen, CN
Received
April 27, 2022
Decision date
September 27, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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K230176Upper Arm Blood Pressure MonitorDXN · Traditional 06/29/2023SE
K221212Upper Arm Blood Pressure MonitorDXN · Traditional 08/26/2022SE

Questions and answers

When was Infrared thermometer cleared by the FDA?

Infrared thermometer (K221211) received a 510(k) decision of Substantially Equivalent on September 27, 2022, 153 days after the submission was received.

What is the product code of K221211?

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