Cleared Traditional

K983490 - TERUMO VENOJECT

K983490 is the FDA 510(k) clearance for TERUMO VENOJECT by Terumo Corp.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K983490 · Terumo Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
56d
Days
Class 2
Risk

K983490 is an FDA 510(k) clearance for the TERUMO VENOJECT,LUER ADAPTER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on November 30, 1998 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Corp. devices

Submission Details

510(k) Number K983490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1998
Decision Date November 30, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
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 114
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K983490.
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VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET
K980414 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1998
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
K974374 · Ohmeda Medical · Jan 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
K965202 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1997