Cleared Traditional

K011699 - VACUETTE EVACUATED BLOOD COLLECTION TUBES

K011699 is an FDA 510(k) clearance for VACUETTE EVACUATED BLOOD COLLECTION TUBES, manufactured by Greiner Bio-One Vacuette North America. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K011699 · Greiner Bio-One Vacuette North America · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
27d
Days
Class 2
Risk

K011699 is an FDA 510(k) clearance for the VACUETTE EVACUATED BLOOD COLLECTION TUBES. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Bio-One Vacuette North America (Baldwin, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 27 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 Greiner Bio-One Vacuette North America devices

FDA 510(k) Submission Details - K011699

510(k) Number K011699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2001
Decision Date June 28, 2001
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 149
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K011699.
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538
K022426 · Becton, Dickinson & CO · Aug 2002
BD VACUTAINER PLUS PST II TUBE
K022130 · Becton, Dickinson & CO · Jul 2002
BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · Becton, Dickinson & CO · Feb 2002
VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1999
MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
K991702 · Becton Dickinson Vacutainer Systems · Jul 1999
GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
K992244 · Greiner Meditech, Inc. · Jul 1999