# K011984: BD Vacutainer Push Button Blood Colection Set

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Aug 29, 2001 after 64 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970259 (1997). 5 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921636: Vacutainer (R) Brand Safety-Lok Blood Collect Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 3.
- K931367: Vacutainer Brand Luer Adapter, Bd Becton Dickinson Vacutainer Systems Preanalytic (1993) Summary page 3.
- K965202: Vacutainer Brand Safety-Lok Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1997) Summary page 3.
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 3.

## Most influential descendants
- K022875: Modification to BD Vacutainer Push Button Blood Collection Set (2002), 18 descendants of its own
- K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341 (2003), 17 descendants of its own
- K153309: BD Vacutainer UltraTouch Push Button Blood Collection Set (2016), 6 descendants of its own
- K192247: Steripath Gen2 Blood Collection System (2020), 5 descendants of its own
- K213718: SOL-GUARD Safety Pull Button Collection Set (2022), 2 descendants of its own

## Recalls of this device
- Jul 31, 2019 · Class II · Z-0193-2020: Separation of front and rear barrels upon activation of the safety feature that retracts the needle
- Oct 5, 2010 · Not classified · Z-0816-2011: There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub.
- Nov 20, 2007 · Not classified · Z-0589-2008: Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
- Nov 20, 2007 · Not classified · Z-0590-2008: Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
- Aug 11, 2006 · Not classified · Z-0034-2007: A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon
- Dec 1, 2005 · Not classified · Z-0372-06: Cracked finger grip luer adapter components on the Push Button Blood Collection Set.
- Dec 17, 2003 · Not classified · Z-0549-04: A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.

## Indications for use
The BD VACUTAINER™ Push Button Blood Collection Set is a sterile, multiple-sample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.

Source page: https://510kreport.com/device/K011984
Methodology: https://510kreport.com/methodology