Cleared Traditional

K152924 - TIVA¿

K152924 is an FDA 510(k) clearance for TIVA¿, manufactured by Velano Vascular. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K152924 · Velano Vascular · Chemistry device
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Jan 2016
Decision
94d
Days
Class 2
Risk

K152924 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 (Philadelphia, US). The FDA issued a Cleared decision on January 7, 2016 after a review of 94 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 devices

FDA 510(k) Submission Details - K152924

510(k) Number K152924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date January 07, 2016
Days to Decision 94 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
6d slower than avg
Panel avg: 88d · This submission: 94d
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 180
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K152924.
Kurin Blood Culture Collection Set
K162233 · Pathway, LLC · Dec 2016
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K160657 · Becton, Dickinson and Company · Sep 2016
BD Vacutainer UltraTouch Push Button Blood Collection Set
K153309 · Becton, Dickinson and Company · Feb 2016
TIVA
K142946 · Velano Vascular, Inc. · Jan 2015
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
K133303 · Bio-Analysis, Inc. · Nov 2014
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
K123987 · Innovative Medical Technologies, Inc. · Aug 2013