# K210444: EZ-Injec LDV Sterile Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: Poonglim Pharmatech, Inc.
- Decided: Feb 16, 2021 after 0 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: 5 generations back to K944355 (1994). 5 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192222: EZ-Inject Single use Needle, Poonglim Pharmatech, Inc. (2020) Summary page 4.

## Most influential descendants
- K221860: PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe (2023), 1 descendant of its own
- K250284: TSK SELECT™ Needle (2025), 0 descendants of its own
- K241190: PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe (2024), 0 descendants of its own
- K231734: STERiJECT Low Dead Space, STERiJECT The Invisible Needle (2024), 0 descendants of its own
- K231165: Shina Syringe; Shina Safety Syringe (2023), 0 descendants of its own

## Indications for use
This product is intended for use to inject fluid into or withdraw fluids from parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K210444
Methodology: https://510kreport.com/methodology