Cleared Traditional

K192210 - ESOTEST MULTI Esophageal Temperature Pr...

K192210 is the FDA 510(k) clearance for ESOTEST MULTI Esophageal Temperature Pr... by Fiab Spa. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K192210 · Fiab Spa · General Hospital
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Oct 2019
Decision
57d
Days
Class 2
Risk

K192210 is an FDA 510(k) clearance for the ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Fiab Spa (Vicchio, IT). The FDA issued a Cleared decision on October 10, 2019 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fiab Spa devices

Submission Details

510(k) Number K192210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2019
Decision Date October 10, 2019
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 K192210.
Infrared Thermometer, Breeze model
K191283 · Suzhou Melodicare Medical Technology Co., Ltd. · Oct 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
Reusable Temperature Probe
K182751 · Shenzhen Caremed Medical Technology Co., Ltd. · Sep 2019
Advocate Non-Contact Infrared Thermometer
K191004 · Broadmaster Biotech, Corp. · Sep 2019
Infrared Ear/Forehead Thermometer
K190873 · Joytech Healthcare Co. , Ltd. · Jul 2019