# K172483: Kopac Sterile Needle

- Pathway: 510(k) (Traditional)
- Applicant: Poonglim Pharmatech, Inc.
- Decided: Jun 21, 2018 after 309 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: 3 generations back to K944355 (1994). 3 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K102584: Imc Hypodermic Needle, International Medsurg Connection (2011) Summary page 4.

## Most influential descendants
- K192222: EZ-Inject Single use Needle (2020), 7 descendants of its own
- K210444: EZ-Injec LDV Sterile Safety Needle (2021), 6 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K172483
Methodology: https://510kreport.com/methodology