# K121488: JMS Safe Wing Cath (SWC)

- Pathway: 510(k) (Traditional)
- Applicant: JMS North America Corporation
- Decided: Mar 5, 2013 after 291 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K032843 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102520: BD Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2011) Summary page 1.
- K895481: Shamrock Safety Winged Infusion Set, Ryan Medical, Inc. (1989) Summary page 1.

## Indications for use
JMVS Safe Wing Cath (SWC) is intended far short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick Injuries.

Source page: https://510kreport.com/device/K121488
Methodology: https://510kreport.com/methodology