Cleared Traditional

K101838 - VTS1000

K101838 is an FDA 510(k) clearance for VTS1000, manufactured by Vuetek Scientific, LLC. The device is a Class 1 General Hospital device with product code KZA cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K101838 · Vuetek Scientific, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
232d
Days
Class 1
Risk

K101838 is an FDA 510(k) clearance for the VTS1000. Classified as Device, Vein Location, Liquid Crystal (product code KZA), Class I - General Controls.

Submitted by Vuetek Scientific, LLC (Marietta, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 232 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6970 - 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 Vuetek Scientific, LLC devices

FDA 510(k) Submission Details - K101838

510(k) Number K101838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date February 18, 2011
Days to Decision 232 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
103d slower than avg
Panel avg: 129d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

KZA Device Classification - Class 1, General Controls

Product Code KZA Device, Vein Location, Liquid Crystal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6970
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.