# K033478: Vacuette Quickshield Safety Tube Holder

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Vacuette North America
- Decided: Dec 29, 2003 after 56 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 K972404 (1997). 2 ancestors in all.
5 later devices descend from it; 2 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)
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608, Becton Dickinson Vacutainer Systems (1998) Summary page 1.

## Most influential descendants
- K102774: Vacuette Quickshield with Snappy Tude Holder (2010), 2 descendants of its own
- K113505: Vacuette Quickshield with Snappy Tube Holder (2012), 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
- K173279: RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (2018), 0 descendants of its own

## Indications for use
The VACUETTE® QUICKSHIELD Safety Tube Holder is to be used together only with VACUETTE® Multi-Sample Needles and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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/K033478
Methodology: https://510kreport.com/methodology