# K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Na, Inc.
- Decided: Apr 19, 2018 after 129 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: 4 generations back to K912563 (1991). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121908: Safety Infusion Set, Greiner Bio-One North America, Inc. (2012) Summary page 4.

## Most influential descendants
- K214075: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (2022), 1 descendant of its own
- K232881: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder (2023), 0 descendants of its own

## Indications for use
The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Source page: https://510kreport.com/device/K173757
Methodology: https://510kreport.com/methodology