Cleared Traditional

K991551 - VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE

K991551 is an FDA 510(k) clearance for VACUTAINER BRAND SODIUM CITRATE PEDIATR..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K991551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
143d
Days
Class 2
Risk

K991551 is an FDA 510(k) clearance for the VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 143 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K991551

510(k) Number K991551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date September 23, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 88d · This submission: 143d
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 171
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K991551.
BD VACUTAINER PLUS PST II TUBE
K022130 · Becton, Dickinson & CO · Jul 2002
BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · Becton, Dickinson & CO · Feb 2002
APPRAISE-CARDIO SAMPLE COLLECTION KIT
K993787 · Osborn Group, Inc. · Apr 2000
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
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
K991843 · Greiner Meditech, Inc. · Jun 1999