Cleared Traditional

K181013 - Fever Scout

K181013 is the FDA 510(k) clearance for Fever Scout by VivaLNK, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K181013 · VivaLNK, Inc. · General Hospital
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Aug 2018
Decision
126d
Days
Class 2
Risk

K181013 is an FDA 510(k) clearance for the Fever Scout. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by VivaLNK, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 21, 2018 after a review of 126 days - within the typical 510(k) review window.

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 VivaLNK, Inc. devices

Submission Details

510(k) Number K181013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2018
Decision Date August 21, 2018
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 317
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K181013.
Temperature Probe
K173194 · Orantech, Inc. · Oct 2018
Infrared Ear Thermometer
K181081 · Joytech Healthcare Co. , Ltd. · Oct 2018
Probe Covers for Thermometers
K180714 · K-Jump Health Co., Ltd. · Sep 2018
Vicks RapidRead Digital Thermometer
K180131 · Kaz USA, Inc., A Helen of Troy Company · Aug 2018
Ageless Health Medical Digital Thermometer
K172508 · Ageless Health Industrial Co., Ltd. · Aug 2018
Non-contact infrared body thermometer
K171888 · Hetaida Technology Co., Ltd. · Jul 2018