# K163073: Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

- Pathway: 510(k) (Traditional)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: May 19, 2017 after 198 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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 K970259 (1997). 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)
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 5.

## Most influential descendants
- K262215: Profoject™ Safety Sliding Blood Collection Set (2026), 0 descendants of its own

## Indications for use
The Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder) is a single-use, sterile, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury

Source page: https://510kreport.com/device/K163073
Methodology: https://510kreport.com/methodology