# K030683: Nipro Disposable Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Oct 31, 2003 after 240 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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.
23 later devices descend from it; 4 cite it directly.
0 of 25 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
- K051574: Nipro Disposable Syringe with or Without Needle (2005), 10 descendants of its own
- K061194: Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558 (2006), 9 descendants of its own
- K063280: Injekt Syringe (2006), 8 descendants of its own
- K071785: Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with Syringe (2007), 7 descendants of its own
- K211634: Hypodermic Needle-Pro EDGE Safety Device (2021), 5 descendants of its own

## Indications for use
The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K030683
Methodology: https://510kreport.com/methodology