Cleared Traditional

K120490 - QUICK SAMPLER HOLDER

K120490 is the FDA 510(k) clearance for QUICK SAMPLER HOLDER by Nipro Medical Corporation. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K120490 · Nipro Medical Corporation · Chemistry device
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Dec 2012
Decision
314d
Days
Class 2
Risk

K120490 is an FDA 510(k) clearance for the QUICK SAMPLER HOLDER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nipro Medical Corporation devices

Submission Details

510(k) Number K120490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date December 27, 2012
Days to Decision 314 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
226d slower than avg
Panel avg: 88d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 115
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K120490.
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