Cleared Traditional

K142946 - TIVA

K142946 is an FDA 510(k) clearance for TIVA, manufactured by Velano Vascular, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K142946 · Velano Vascular, Inc. · Chemistry device
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Jan 2015
Decision
90d
Days
Class 2
Risk

K142946 is an FDA 510(k) clearance for the TIVA. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Velano Vascular, Inc. (Philadelphia, US). The FDA issued a Cleared decision on January 8, 2015 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Velano Vascular, Inc. devices

FDA 510(k) Submission Details - K142946

510(k) Number K142946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2014
Decision Date January 08, 2015
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 164
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