# K102774: Vacuette Quickshield with Snappy Tude Holder

- Pathway: 510(k) (Special)
- Applicant: Greiner Bio-One North America, Inc.
- Decided: Oct 15, 2010 after 21 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972404 (1997). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033478: Vacuette Quickshield Safety Tube Holder, Greiner Bio-One Vacuette North America (2003) Summary page 1.

## Most influential descendants
- K113505: Vacuette Quickshield with Snappy Tube Holder (2012), 1 descendant of its own
- K173279: RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (2018), 0 descendants of its own

## Recalls of this device
- Aug 11, 2011 · Not classified · Z-0179-2012: Reports of the Vacuette QuickShield Safety Holders breaking during use due to a crack at the holder hub.

## Indications for use
Intended Use: The VACUETTE® QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with VACUETTE® VISIO PLUS Blood Collection Needle with View Window and VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. These devices are to be used by properly trained healthcare professionals only in accordance with these instructions.

Source page: https://510kreport.com/device/K102774
Methodology: https://510kreport.com/methodology