# K262215: Profoject™ Safety Sliding Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Sep 25, 2026 after 87 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: 3 generations back to K970259 (1997). 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)
- K163073: Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder, Sol-Millennium Medical, Inc. (2017) Summary page 6.

## Indications for use
The Profoject™ Safety Sliding Blood Collection Set 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/K262215
Methodology: https://510kreport.com/methodology