# K090426: Vaku-8 Blood Collection Needles

- Pathway: 510(k) (Traditional)
- Applicant: Myco Medical Supplies, Inc.
- Decided: Jun 12, 2009 after 113 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 K861152 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992699: Nipro Blood Collection Needle, Nipro Medical Corp. (2000) Summary page 2.

## Most influential descendants
- K153388: IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle (2016), 0 descendants of its own

## Indications for use
VAIKU-8 T m Blood Collection Needles are designed for routine blood collection by a qualified practitioner

Source page: https://510kreport.com/device/K090426
Methodology: https://510kreport.com/methodology