# K980768: Vacuette Holdex

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Meditech, Inc.
- Decided: Apr 9, 1998 after 41 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921520 (1992). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921520: Vacutainer Brand Luer Adapter, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.

## Most influential descendants
- K160532: Greiner Holdex (2016), 1 descendant of its own
- K180545: VACUETTE SAFELINK Holder with male luer lock (2018), 0 descendants of its own

## Recalls of this device
- Jun 29, 2011 · Not classified · Z-2957-2011: At removal of the tube from the holder, the needle may dislodge and blood spill can occur.
- Aug 5, 2008 · Not classified · Z-2198-2008: At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
- May 16, 2008 · Not classified · Z-2134-2008: At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.

## Indications for use
To be used in routine venipuncture procedures using butterfly needles and/or hypodermic luer needles.

Source page: https://510kreport.com/device/K980768
Methodology: https://510kreport.com/methodology