# K160532: Greiner Holdex

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Na, Inc.
- Decided: Nov 3, 2016 after 251 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: 3 generations back to K931367 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980768: Vacuette Holdex, Greiner Meditech, Inc. (1998) Summary page 4.
- K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle, Becton Dickinson Vacutainer Systems (1999) Summary page 4.

## Most influential descendants
- K180545: VACUETTE SAFELINK Holder with male luer lock (2018), 0 descendants of its own

## Indications for use
The HOLDEX® Single-Use Holder PP is for use in venous blood collection procedures in combination with blood collection devices with a female luer port.

Source page: https://510kreport.com/device/K160532
Methodology: https://510kreport.com/methodology