# K231734: STERiJECT Low Dead Space, STERiJECT The Invisible Needle

- Pathway: 510(k) (Traditional)
- Applicant: Tsk Laboratory International Japan KK
- Decided: Mar 8, 2024 after 268 days
- Product code: QNS (Low Dead Space Needle, Single Lumen, Hypodermic)
- 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 4.
- K970370: TSK Sterijekt Premium Disposable Hypodermic Needle, Tsk Laboratory, Japan (1997) Summary page 4.

## Indications for use
This device is intended to inject into or aspirate from, the body.

Source page: https://510kreport.com/device/K231734
Methodology: https://510kreport.com/methodology