# K102584: Imc Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection
- Decided: Jan 14, 2011 after 128 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944355 (1994). 2 ancestors in all.
12 later devices descend from it; 4 cite 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)
- K052474: Nipro Hypodermic Needle, Nipro Medical Corp. (2005) Summary page 1.

## Most influential descendants
- 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
- K250284: TSK SELECT™ Needle (2025), 0 descendants of its own

## Recalls of this device
- Jun 23, 2017 · Class II · Z-2822-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2811-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2809-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2813-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2805-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2812-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2814-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2815-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2807-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2818-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2806-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2816-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2810-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2817-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2820-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2821-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2819-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2823-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2824-2017: Insufficient documentation to support product sterility claims.
- Jun 23, 2017 · Class II · Z-2808-2017: Insufficient documentation to support product sterility claims.

## 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/K102584
Methodology: https://510kreport.com/methodology