Cleared Special

K122412 - VISIOFOCUS

K122412 is an FDA 510(k) clearance for VISIOFOCUS, 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 217-day FDA review.

K122412 · Tecnimed S.R.L. · General Hospital
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Mar 2013
Decision
217d
Days
Class 2
Risk

K122412 is an FDA 510(k) clearance for the VISIOFOCUS. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Tecnimed S.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on March 13, 2013 after a review of 217 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. 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. Standard predicate reliance. 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 - K122412

510(k) Number K122412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date March 13, 2013
Days to Decision 217 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 129d · This submission: 217d
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 K122412.
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
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GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
K121999 · Draeger Medical GmbH · Feb 2013
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K123361 · Fiab Spa · Feb 2013
DIGITAL THERMOMTER
K122520 · Taidoc Technology Corporation · Feb 2013
K122412 · VISIOFOCUS
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