Cleared Traditional

DeRoyal Temperature Monitoring Probe

K200631 · Deroyal Industries, Inc. · General Hospital

Dec 2020

Decision

288d

Days

Class 2

Risk

About This 510(k) Submission

K200631 is an FDA 510(k) clearance for the DeRoyal Temperature Monitoring Probe, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on December 23, 2020, 288 days after receiving the submission on March 10, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K200631 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2020
Decision Date	December 23, 2020
Days to Decision	288 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.