Cleared Traditional

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304

K211050 · Jkh Health Co., Ltd. · General Hospital

Nov 2022

Decision

599d

Days

Class 2

Risk

About This 510(k) Submission

K211050 is an FDA 510(k) clearance for the Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 28, 2022, 599 days after receiving the submission on April 8, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K211050 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2021
Decision Date	November 28, 2022
Days to Decision	599 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	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.