# K971449: Vacutainer Brand Plus Tube with Edta Anticoagulant (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Jun 17, 1997 after 57 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has 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 Tube with EDTA Anticoagulant: named in the summary without a submission number

## Recalls of this device
- Mar 22, 2018 · Class I · Z-1140-2018: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCar

## Indications for use
The VACUTAINER® Brand PLUS (plastic) Tube with EDTA is an evacuated blood collection tube which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein. Blood collected in a tube containing EDTA Anticoagulant is primarily used for clinical laboratory testing-hematology study using whole blood but may be used for other studies including such studies as testing for lead and FEP analyses, requiring whole blood as determined by the laboratory.

Source page: https://510kreport.com/device/K971449
Methodology: https://510kreport.com/methodology