# K972404: Vacutainer Brand Safety Blood Collection Assembly (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jul 22, 1997 after 26 days
- Product code: KJA (Flask, Tissue Culture)
- Device class: 1
- Regulation: 21 CFR 864.2240
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
127 later devices descend from it; 2 cite it directly.
0 of 128 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 no predicate by number.

## Most influential descendants
- K021475: BD Single Lumen Needle, Syringe and Blood Collection Set (2002), 100 descendants of its own
- K070440: BD Hypoint Needle (2007), 91 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own

## Recalls of this device
- Mar 7, 2019 · Class II · Z-1122-2019: The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannu

## Indications for use
The VACUTAINER® Brand Safety Blood Collection Assembly is intended to provide a pre-assembled Direct Draw Adapter/safety needle combination for venipuncture to obtain blood samples. The VACUTAINER® Brand Safety Blood Collection Assembly contains a sliding shield that covers the needle point after use. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.

Source page: https://510kreport.com/device/K972404
Methodology: https://510kreport.com/methodology