# K182538: Merit RadialFlo Arterial Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Merit Medical Singapore Pte., Ltd.
- Decided: Jan 16, 2019 after 124 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 K013800 (2001). 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)
- K151698: BD Angiocath IV Catheter, BD Insyte IV Catheter, Becton Dickinson Infusion Therapy Systems, Inc. (2015) Summary page 4.

## Indications for use
The Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Source page: https://510kreport.com/device/K182538
Methodology: https://510kreport.com/methodology