# K102010: Vacuette Premium Safety Blood Collection Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Medpro Safety Products, Inc.
- Decided: Nov 19, 2010 after 126 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: 3 generations back to K970259 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011786: Vacuette Safety Blood Collection Set, Greiner Vacuette North America, Inc. (2001) Summary page 1.
- K011984: BD Vacutainer Push Button Blood Colection Set, Becton, Dickinson & CO (2001) Summary page 1.

## Most influential descendants
- K181508: U&U Blood Collection Sets (2019), 0 descendants of its own

## Indications for use
VACUJETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. it is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury.

Source page: https://510kreport.com/device/K102010
Methodology: https://510kreport.com/methodology