Cleared Traditional

VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT (K080816) - FDA 510(k) Clearance

Class I General Hospital device.

K080816 · Visual Footcare Technologies, LLC · General Hospital
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Jun 2008
Decision
92d
Days
Class 1
Risk

K080816 is an FDA 510(k) clearance for the VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT. Classified as Foot Examination Tool For Inflammatory Changes (product code OIZ), Class I - General Controls.

Submitted by Visual Footcare Technologies, LLC (South Salem, US). The FDA issued a Cleared decision on June 24, 2008 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - 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.

View all Visual Footcare Technologies, LLC devices

Submission Details

510(k) Number K080816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2008
Decision Date June 24, 2008
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OIZ Foot Examination Tool For Inflammatory Changes
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
Definition Assist A Patient To Visualize The Image And Condition Of The Soles Of Their Feet In Connection With A Daily Self-examination For Signs Of Inflammation On The Sole Of The Foot. The Device Will Assist The Patient In Determining When They Should Contact Their Healthcare Provider For Further Diagnosis And Treatment Regarding Any Skin Changes Seen By A Mirror And/or Highlighted By The Liquid Crystal Foot Pads. Intended To Be Used As An Adjunct To, And Not In Replacement Of, Periodic Foot Care And Examinations Conducted By A Health Care Professional And Used Under The Direction Of A Health Care Professional And Does Not Diagnose Any Specific Disease State.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.