Cleared Traditional

K162233 - Kurin Blood Culture Collection Set

K162233 is the FDA 510(k) clearance for Kurin Blood Culture Collection Set by Pathway, LLC. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K162233 · Pathway, LLC · Chemistry device
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Dec 2016
Decision
137d
Days
Class 2
Risk

K162233 is an FDA 510(k) clearance for the Kurin Blood Culture Collection Set. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Pathway, LLC (Santee, US). The FDA issued a Cleared decision on December 23, 2016 after a review of 137 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.

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Submission Details

510(k) Number K162233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date December 23, 2016
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 116
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