Cleared Traditional

K131155 - UGFT3

Also marketed or referenced as:
FHT7

K131155 is an FDA 510(k) clearance for UGFT3, manufactured by Medisim, Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K131155 · Medisim, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
126d
Days
Class 2
Risk

K131155 is an FDA 510(k) clearance for the UGFT3. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Medisim, Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on August 28, 2013 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.

FDA 510(k) Submission Details - K131155

510(k) Number K131155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date August 28, 2013
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.

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 679
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K131155.
NON-CONTACT INFRARED THERMOMETER
K131243 · Shenzhen Jumper Medical Equipment Co., Ltd. · Nov 2013
NON-CONTACT INFRARED THERMOMETER
K130231 · Jinxinbao Electronic Co.,Ltd · Oct 2013
CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
K131771 · Thermomedics, Inc. · Oct 2013
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
K120671 · Cotronic Technology Limited · May 2013
THERMOFINDER
K130361 · Hubdic Co., Ltd. · Apr 2013
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · Taidoc Technology Corporation · Mar 2013
K131155 · UGFT3
Download PDF FDA Summary Medisim, Ltd.