Cleared Traditional

K991702 - MICROTAINER BRAND CHEMISTRY TUBES WITH ...

K991702 is the FDA 510(k) clearance for MICROTAINER BRAND CHEMISTRY TUBES WITH ... by Becton Dickinson Vacutainer Systems. It is a Class 2 Toxicology device (product code JKA) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K991702 · Becton Dickinson Vacutainer Systems · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
70d
Days
Class 2
Risk

K991702 is an FDA 510(k) clearance for the MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 36598.... 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 July 28, 1999 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - the FDA toxicology 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: 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 Becton Dickinson Vacutainer Systems devices

Submission Details

510(k) Number K991702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1999
Decision Date July 28, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 87d · This submission: 70d
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 Toxicology devices follow this clearance model.

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

All 116
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K991702.
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K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1999
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