# K111424: Vacuette Premium Safety Needle System Tube-Touch

- Pathway: 510(k) (Special)
- Applicant: Medpro Safety Products, Inc.
- Decided: Jul 29, 2011 after 67 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 K003406 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072602: Vacuette Premium Safety Needle System, Medpro Safety Products, Inc. (2008) Summary page 1.

## Most influential descendants
- K120281: Dignity Power Injectable Titanium Port (2012), 0 descendants of its own

## Indications for use
The VACUETTE® PREMIUM Safety Needle System Tube-Touch is used in routine venipuncture procedures. The Needle System is designed with an integrated, multiple sample needle and safety shield. The safety shield is automatically activated and released upon insertion of the first blood collection tube and covers the needle immediately following blood collection from patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

Source page: https://510kreport.com/device/K111424
Methodology: https://510kreport.com/methodology