# K981619: Vacuette Multiple Sample Luer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Meditech, Inc.
- Decided: Jul 15, 1998 after 70 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 K950159 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950159: Suresharp, Gainor Medical U.S.A., Inc. (1995) Summary page 1.

## Indications for use
For use in venous blood collection with attached butterfly needle or luer needle.

Source page: https://510kreport.com/device/K981619
Methodology: https://510kreport.com/methodology