# K131641: Monoject 60ML Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip)

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Aug 28, 2013 after 85 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K771205 (1977). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980987: Becton Dickinson Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K063613: Modification to Terumo Syringe with/Without Needle, Terumo Medical Corp. (2006) Summary page 1.

## Recalls of this device
- Apr 23, 2024 · Class II · Z-2039-2024: Quarantined product was inadvertently distributed

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

Source page: https://510kreport.com/device/K131641
Methodology: https://510kreport.com/methodology