# K250284: TSK SELECT™ Needle

- Pathway: 510(k) (Traditional)
- Applicant: Tsk Laboratory, Japan
- Decided: Jul 24, 2025 after 174 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: 6 generations back to K944355 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210444: EZ-Injec LDV Sterile Safety Needle, Poonglim Pharmatech, Inc. (2021) Summary page 5.

## Indications for use
The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.

Source page: https://510kreport.com/device/K250284
Methodology: https://510kreport.com/methodology