Cleared Traditional

K122355 - VANISHPOINT BLOOD COLLECTION SET

K122355 is an FDA 510(k) clearance for VANISHPOINT BLOOD COLLECTION SET, manufactured by Retractable Technologies, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K122355 · Retractable Technologies, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 2013
Decision
385d
Days
Class 2
Risk

K122355 is an FDA 510(k) clearance for the VANISHPOINT BLOOD COLLECTION SET. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Retractable Technologies, Inc. (Little Elm, US). The FDA issued a Cleared decision on August 23, 2013 after a review of 385 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 Retractable Technologies, Inc. devices

FDA 510(k) Submission Details - K122355

510(k) Number K122355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2012
Decision Date August 23, 2013
Days to Decision 385 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
297d slower than avg
Panel avg: 88d · This submission: 385d
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 187
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K122355.
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K122687 · Greiner Bio-One North America, Inc. · Jan 2013
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K120490 · Nipro Medical Corporation · Dec 2012
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR
K103041 · Greiner Bio-One North America, Inc. · Nov 2010