# K974006: Becton Dickinson Twinpak

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jan 22, 1998 after 93 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920422 (1992). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920422: B-D Interlink Syringe Cannula, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 2.
- (no number) Becton Dickinson 20G hypodermic needle: named in the summary without a submission number
- (no number) Becton Dickinson Tubing Adapter: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K883583: Becton Dickinson Interlink® Vial Access Cannula. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K170900: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories (2017), 1 descendant of its own
- K102328: Blunt Fill Needle and Blunt Plastic Cannula (2011), 1 descendant of its own
- K201031: NRFit® Caps, Male and Female Neuraxial Tip Caps (2020), 0 descendants of its own
- K120420: Sterile Blunt for Single Use (2012), 0 descendants of its own

## Indications for use
The syringe filling device component of B-D® TWINPAK™ is for use in drawing up fluids/medications from vials and ampoules without requiring other accessories. Once the syringe is filled, the filling device is detached from the syringe. The syringe is then reattached to the blunt plastic cannula which provides access to fluid path for injection/aspiration of fluids. The B-D® TWINPAK™ offers the convenience of delivering a syringe filling device and a blunt plastic cannula for access into split septum IV sites for injection/aspiration of fluids.

Source page: https://510kreport.com/device/K974006
Methodology: https://510kreport.com/methodology