# K130049: Monoject 12ML Syringe

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Feb 14, 2013 after 37 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The syringe is intended to inject or withdraw fluids from the body.

Source page: https://510kreport.com/device/K130049
Methodology: https://510kreport.com/methodology