# K160657: BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Sep 23, 2016 after 199 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954592 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954592: Vacutainer Brand PST Plasma Separation Tube, Becton Dickinson Vacutainer Systems (1995) Summary page 6.

## Recalls of this device
- Mar 22, 2018 · Class I · Z-1142-2018: 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
- Sep 18, 2017 · Class II · Z-1180-2018: Increased amount of residual blood present on the top of stopper well after venipuncture

## Indications for use
BD Vacutainer® Barricor™ Lithium Heparin Plasma Blood Collection Tubes (BD Barricor™ Tubes) are used to collect, separate, process, transport, and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring, and zinc testing in plasma for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker.

Source page: https://510kreport.com/device/K160657
Methodology: https://510kreport.com/methodology