Cleared Special

K072108 - MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES

K072108 is an FDA 510(k) clearance for MODIFICATION TO THERMOFOCUS 0800, manufactured by Tecnimed S.R.L.. The device is a Class 2 General Hospital device with product code FLL cleared through the Special 510(k) pathway after a 30-day FDA review.

K072108 · Tecnimed S.R.L. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
30d
Days
Class 2
Risk

K072108 is an FDA 510(k) clearance for the MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Tecnimed S.R.L. (Great Neck, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072108

510(k) Number K072108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date August 31, 2007
Days to Decision 30 days
Submission Type Special
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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 794
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K072108.
DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
K072641 · Famidoc Technology Co., Ltd. · Nov 2007
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
K070339 · Cincinnati Sub-Zero Products, Inc. · Sep 2007
MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
K070590 · Microlife Intellectual Property GmbH · Sep 2007
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER
K070578 · Zen Strong Medical Technology Co., Ltd. · Jul 2007
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K070491 · K-Jump Health Co., Ltd. · Jun 2007
DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
K070878 · Rg Medical Diagnostics · Jun 2007
K072108 · MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
Download PDF FDA Summary Tecnimed S.R.L.