# K043328: Microflo-Safe Scalp Vein Set

- Pathway: 510(k) (Traditional)
- Applicant: Dks Loversan Industria Biomedica Spa
- Decided: Apr 15, 2005 after 134 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K970259 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031279: Surshield Safety Winged Blood Collection Set, Terumo Medical Products Hangzhou Co., Ltd. (2003) Summary page 1.
- K000592: Unolok Plus Infusion Set and Vaku-8 Plus Blood Collection Set, Myco Medical Supplies, Inc. (2001) Summary page 1.
- K000714: Vacuflow+Safe Blood Collection Set and Vacuflow+Safe with Holder Blood Collection Set, Med-Pro Technologies, Inc. (2000) Summary page 1.

## Indications for use
The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Source page: https://510kreport.com/device/K043328
Methodology: https://510kreport.com/methodology