# K110656: Imc Blood Collection Needle

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection
- Decided: Aug 18, 2011 after 164 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 K950159 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061483: Vacuette Visio Plus Blood Collection Needles, Greiner Bio-One North America, Inc. (2006) Summary page 1.

## Indications for use
This device is intended for use in venous blood collection.

Source page: https://510kreport.com/device/K110656
Methodology: https://510kreport.com/methodology