# K052474: Nipro Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Nov 10, 2005 after 62 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: 1 generation back to K944355 (1994). 1 ancestor in all.
13 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944355: Nipro Branded Disposable Syringes, Needles, Nissho Corp. (1994) Summary page 1.

## Most influential descendants
- K102584: Imc Hypodermic Needle (2011), 12 descendants of its own
- K172483: Kopac Sterile Needle (2018), 8 descendants of its own
- 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

## Indications for use
The Nipro Hypodermic Needle 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/K052474
Methodology: https://510kreport.com/methodology