# K992145: Ecomed Scalp Vein Set

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Meditech, Inc.
- Decided: Oct 14, 1999 after 112 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970259 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.

## Recalls of this device
- Dec 16, 2003 · Not classified · Z-0388-04: Product may have a defective connection.

## Indications for use
The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.

Source page: https://510kreport.com/device/K992145
Methodology: https://510kreport.com/methodology