# K080235: Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Vacuette North America
- Decided: Apr 24, 2008 after 85 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: 2 generations back to K912563 (1991). 3 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K011297: Nipro Safetouch Scalp Vein and Blood Collection Set, Nipro Medical Corp. (2001)
- K011786: Vacuette Safety Blood Collection Set, Greiner Vacuette North America, Inc. (2001) Summary page 1.

## Most influential descendants
- K121908: Safety Infusion Set (2012), 6 descendants of its own
- 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

## Indications for use
The VACUETTE® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tbbing 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/K080235
Methodology: https://510kreport.com/methodology