# K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341

- Pathway: 510(k) (Traditional)
- Applicant: Bd Vacutainer Systems Preanalyical Solutions
- Decided: May 8, 2003 after 73 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
Longest line of descent: 4 generations back to K970259 (1997). 7 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K022875: Modification to BD Vacutainer Push Button Blood Collection Set, Becton, Dickinson & CO (2002)

## Most influential descendants
- 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
- K200661: Steripath Micro Blood Collection System (2020), 2 descendants of its own
- K220212: BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder (2023), 1 descendant of its own

## Recalls of this device
- Mar 20, 2018 · Class II · Z-1533-2018: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
- Mar 20, 2018 · Class II · Z-1532-2018: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
- Mar 20, 2018 · Class II · Z-1531-2018: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
- Aug 8, 2016 · Class II · Z-0745-2017: BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear ba
- Aug 8, 2016 · Class II · Z-2710-2016: Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of

## Indications for use
The BD VacutainerTM 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 BD VacutainerTM Push Button Blood Collection Set is also iindicated for intravenous administration of fluids as indicated in 21 CFR 5880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy. 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 accidental needlestick injury.

Source page: https://510kreport.com/device/K030573
Methodology: https://510kreport.com/methodology