# K112542: Yomura Safety I.V. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Yomura Technologies, Inc.
- Decided: Feb 8, 2012 after 160 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: 1 generation back to K962226 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962226: Protectiv 2000 I.V. Catheter Safety System, Johnson & Johnson Medical, Inc. (1996) Summary page 1.
- K000235: Insyte Catheter, Insyte Autoguard Catheter, Becton Dickinson Infusion Therapy Systems, Inc. (2000) Summary page 1.

## Indications for use
The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.

Source page: https://510kreport.com/device/K112542
Methodology: https://510kreport.com/methodology