# K051574: Nipro Disposable Syringe with or Without Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Aug 26, 2005 after 73 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: 2 generations back to K944355 (1994). 2 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 13 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.
- K030683: Nipro Disposable Syringes, Nipro Medical Corp. (2003) Summary page 1.

## Most influential descendants
- K063280: Injekt Syringe (2006), 8 descendants of its own
- K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet) (2010), 3 descendants of its own
- K071459: B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes (2007), 3 descendants of its own
- K202432: MiniLoad Syringe (2021), 2 descendants of its own
- K241385: Omnifix Syringe NRFit (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K051574
Methodology: https://510kreport.com/methodology