# K202060: Disposable IV catheter

- Pathway: 510(k) (Traditional)
- Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
- Decided: Jul 23, 2021 after 361 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: 8 generations back to K942988 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183399: BD Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2019) Summary page 4.

## Indications for use
Disposable IV catheter is intended to be inserted into a Patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA devices are suitable for use with power injectors set to a maximum pressure of 300 psi when access ports not suitable for use with power injectors are removed.

Source page: https://510kreport.com/device/K202060
Methodology: https://510kreport.com/methodology