Cleared Traditional

K981013 - VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE

K981013 is an FDA 510(k) clearance for VACUTAINER PLUS TUBE WITH EDTA ANTICOAG..., manufactured by Becton Dickinson Vacutainer Systems. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K981013 · Becton Dickinson Vacutainer Systems · Chemistry device
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Jun 1998
Decision
91d
Days
Class 2
Risk

K981013 is an FDA 510(k) clearance for the VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton Dickinson Vacutainer Systems (Franklin Lake, US). The FDA issued a Cleared decision on June 17, 1998 after a review of 91 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.

View all Becton Dickinson Vacutainer Systems devices

FDA 510(k) Submission Details - K981013

510(k) Number K981013 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 18, 1998
Decision Date June 17, 1998
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
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 164
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K981013.
GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
K982999 · Greiner Meditech, Inc. · Oct 1998
VACUTAINER BRAND BLOOD COLLECTION SYRINGE
K982922 · Becton Dickinson Vacutainer Systems · Sep 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K981973 · Ram Scientific · Sep 1998
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
K981035 · Sims Portex, Inc. · Apr 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET
K980414 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1998
VACUETTE (MULTI-USE HOLDER)
K974873 · Greiner Meditech, Inc. · Feb 1998