# K013971: BD Vacutainer Safety Coagulation Tube

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Feb 1, 2002 after 60 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VACUTAINER™ Brand Sodium Citrate Tube: named in the summary without a submission number

## Most influential descendants
- K240455: BD Vacutainer® Citrate Blood Collection Tubes (2024), 0 descendants of its own

## Recalls of this device
- Apr 11, 2018 · Class II · Z-2258-2018: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
- Apr 11, 2018 · Class II · Z-2260-2018: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
- Apr 11, 2018 · Class II · Z-2259-2018: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.
- Jun 23, 2014 · Class II · Z-2633-2014: Products were held at improper storage temperature
- Nov 12, 2012 · Class II · Z-0756-2013: BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.

## Indications for use
The BD Vacutainer™ Safety Coagulation tube is a plastic evacuated blood collection tube that provides a means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. The benefits of a safety plastic coagulation tube with Hemogard Safety Closure Assembly are: ¢ reduced risk of specimen tube breakage ¢ reduced exposure to blood by laboratory personnel and to minimize blood splatter during stopper removal These benefits lead to increased safety of laboratory personnel and reduced necessity of repeat specimen collection.

Source page: https://510kreport.com/device/K013971
Methodology: https://510kreport.com/methodology