# K061483: Vacuette Visio Plus Blood Collection Needles

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One North America, Inc.
- Decided: Aug 14, 2006 after 76 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 K950159 (1995). 2 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K973620: Vacuette Multi-Sample Needle, Greiner Meditech, Inc. (1997) Summary page 1.

## Most influential descendants
- K073127: Blood Collection Needle, Model 20G 21G 22G (2007), 1 descendant of its own
- K072320: Greiner Vacuette Quickshield Complete (2007), 1 descendant of its own
- K233979: VACUETTE® QUICKSHIELD Complete (Plus) (2024), 0 descendants of its own
- K110656: Imc Blood Collection Needle (2011), 0 descendants of its own
- K103587: Disposable Bllod Collection Needle (2011), 0 descendants of its own

## Indications for use
VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner.

Source page: https://510kreport.com/device/K061483
Methodology: https://510kreport.com/methodology