# K072602: Vacuette Premium Safety Needle System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medpro Safety Products, Inc.
- Decided: Jun 18, 2008 after 278 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: 1 generation back to K003406 (2001). 2 ancestors in all.
2 later devices descend 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)
- K003406: Guarded Needle 2000, International Medical Device Partners, Inc. (2001) Summary page 1.
- K003461: BD Vacutainer Passive Shielding Blood Collection Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (2001) Summary page 1.

## Most influential descendants
- K111424: Vacuette Premium Safety Needle System Tube-Touch (2011), 1 descendant of its own
- K120281: Dignity Power Injectable Titanium Port (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K072602
Methodology: https://510kreport.com/methodology