Cleared Traditional

K160680 - VisioFocus Mini, VisioFocus Smart

K160680 is an FDA 510(k) clearance for VisioFocus Mini, manufactured by Tecnimed S.R.L.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K160680 · Tecnimed S.R.L. · General Hospital
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Apr 2017
Decision
405d
Days
Class 2
Risk

K160680 is an FDA 510(k) clearance for the VisioFocus Mini, VisioFocus Smart. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Tecnimed S.R.L. (Vedano Olona, IT). The FDA issued a Cleared decision on April 19, 2017 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Tecnimed S.R.L. devices

FDA 510(k) Submission Details - K160680

510(k) Number K160680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2016
Decision Date April 19, 2017
Days to Decision 405 days
Submission Type Traditional
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
276d slower than avg
Panel avg: 129d · This submission: 405d
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 Consultant

THEMA S.r.l.
Simona Daidone

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 528
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K160680.
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