Cleared Traditional

K191283 - Infrared Thermometer

K191283 is the FDA 510(k) clearance for Infrared Thermometer by Suzhou Melodicare Medical Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K191283 · Suzhou Melodicare Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
158d
Days
Class 2
Risk

K191283 is an FDA 510(k) clearance for the Infrared Thermometer, Breeze model. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Suzhou Melodicare Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 18, 2019 after a review of 158 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 Suzhou Melodicare Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K191283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date October 18, 2019
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
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 K191283.
Infrared Thermometer, model: PC808
K190717 · Shenzhen Pacom Medical Instruments Co., Ltd. · Dec 2019
Digital Thermometer
K183393 · Joytech Healthcare Co. , Ltd. · Nov 2019
Infrared Thermometer Model MD-H30
K191570 · Guangzhou Berrcom Medical Device Co., Ltd. · Nov 2019
Infrared Forehead Thermometer (Model IR-FT)
K191668 · Comper Chuangxiang (Beijing) Technology Co., Ltd. · Oct 2019
Infared Thermometer
K191251 · Shenzhen Calibeur Industries Co., Ltd. · Oct 2019
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K192210 · Fiab Spa · Oct 2019