Cleared Traditional

K202325 - EasyPoint Blood Collection Plus

K202325 is an FDA 510(k) clearance for EasyPoint Blood Collection Plus, manufactured by Retractable Technologies, Inc.. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K202325 · Retractable Technologies, Inc. · General Hospital
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Apr 2021
Decision
235d
Days
Class 2
Risk

K202325 is an FDA 510(k) clearance for the EasyPoint Blood Collection Plus. 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 April 9, 2021 after a review of 235 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Retractable Technologies, Inc. devices

FDA 510(k) Submission Details - K202325

510(k) Number K202325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2020
Decision Date April 09, 2021
Days to Decision 235 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 129d · This submission: 235d
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 General Hospital devices follow this clearance model.

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

All 125
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K202325.
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