# K180545: VACUETTE SAFELINK Holder with male luer lock

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Na, Inc.
- Decided: May 21, 2018 after 81 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931367 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160532: Greiner Holdex, Greiner Bio-One Na, Inc. (2016) Summary page 4.

## Recalls of this device
- Nov 19, 2024 · Class II · Z-0802-2025: The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

## Indications for use
The VACUETTE SAFELINK Holder with male luer lock is for use in blood collection procedures in combination with devices with a female luer port.

Source page: https://510kreport.com/device/K180545
Methodology: https://510kreport.com/methodology