Cleared Traditional

K200631 - DeRoyal Temperature Monitoring Probe

K200631 is an FDA 510(k) clearance for DeRoyal Temperature Monitoring Probe, manufactured by Deroyal Industries, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K200631 · Deroyal Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
288d
Days
Class 2
Risk

K200631 is an FDA 510(k) clearance for the DeRoyal Temperature Monitoring Probe. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on December 23, 2020 after a review of 288 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K200631

510(k) Number K200631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 129d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 527
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K200631.
Non-contact Electronic Forehead Infrared Thermometer
K201582 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · Jan 2021
Non-contact Infrared Body Thermometer, model:HTD8823US
K200159 · Hetaida Technology Co., Ltd. · Jan 2021
iHealth Clinical Digital Thermometer
K202791 · Andon Health Co, Ltd. · Jan 2021
Fever Garde
K191978 · Hubdic Co., Ltd. · Dec 2020
Infrared Thermometer
K201980 · Contec Medical Systems Co.,Ltd · Dec 2020
Infrared Body Thermometer
K200781 · Heitaida Technology Co., Ltd. · Dec 2020