# K121908: Safety Infusion Set

- Pathway: 510(k) (Special)
- Applicant: Greiner Bio-One North America, Inc.
- Decided: Jul 25, 2012 after 26 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 K912563 (1991). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080235: Safety Infusion Set, Greiner Bio-One Vacuette North America (2008) Summary page 1.
- K011786: Vacuette Safety Blood Collection Set, Greiner Vacuette North America, Inc. (2001) Summary page 1.

## Most influential descendants
- K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (2018), 2 descendants of its own
- K170276: Safety Blood Collection Device for Single Use (2017), 2 descendants of its own
- K214075: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (2022), 1 descendant of its own
- K211293: Safety Winged Blood Collection Sets (2021), 1 descendant of its own
- K243806: Safety Winged Blood Collection Sets (2025), 0 descendants of its own

## Indications for use
The VACUETTE® SAFETY Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing* with a luer connector. The VACUETTE® SAFETY Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Source page: https://510kreport.com/device/K121908
Methodology: https://510kreport.com/methodology