# K132321: JMS Syringe

- Pathway: 510(k) (Traditional)
- Applicant: JMS North America Corporation
- Decided: Feb 20, 2014 after 210 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 K991904 (1999). 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)
- K991904: Modification of JMS Needles and JMS Syringes, Jms Co., Ltd. (1999) Summary page 1.

## Indications for use
JMS Syringe is intended to be used to inject fluids into or withdraw fluids out of the body.

Source page: https://510kreport.com/device/K132321
Methodology: https://510kreport.com/methodology