Cleared Traditional

K182078 - MiniCollect K2E K2EDTA Tubes (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182078 · Greiner Bio-One Na, Inc. · Hematology device
Jan 2019
Decision
176d
Days
Class 2
Risk

K182078 is an FDA 510(k) clearance for the MiniCollect K2E K2EDTA Tubes. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Bio-One Na, Inc. (Monroe, US). The FDA issued a Cleared decision on January 25, 2019 after a review of 176 days - an extended review cycle.

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

Submission Details

510(k) Number K182078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2018
Decision Date January 25, 2019
Days to Decision 176 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 205d · This submission: 176d
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 Hematology devices follow this clearance model.

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

All 20
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K182078.
BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes
K252040 · Becton, Dickinson and Company · Mar 2026
Steripath® Flow™ Blood Collection System
K251812 · Magnolia Medical Technologies · Sep 2025
BD Vacutainer® Eclipse™ Blood Collection Needle
K243207 · Becton, Dickinson and Company · Jul 2025
Blood collection tube holders
K250961 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2025
Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · Venocare, Inc. · May 2025
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · Sol-Millennium Medical, Inc. · Apr 2025