# K013293: Nipro Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Dec 14, 2001 after 73 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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
- K021224: Endocervical Block Needle (2002), 1 descendant of its own
- K052365: Cervineedle Disposable Cartridge Syringe (2005), 0 descendants of its own
- K052551: Devon Standard Syringe, Hypodermic Needle and Insulin Syringe (2005), 0 descendants of its own

## Indications for use
The Nipro® Hypodermic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K013293
Methodology: https://510kreport.com/methodology