# K122544: Terumo Surflash Safety I.V. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corporation
- Decided: Sep 5, 2012 after 15 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: 6 generations back to K801941 (1980). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100282: Terumo Surshield- Pur Safety I.V. Catheter, Terumo Corp. (2010) Summary page 3.
- K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter, Terumo Medical Corp. (1999) Summary page 3.
- K971339: Insyte, Insyte-W, Insyte Autoguard Catheters, Becton Dickinson Vascular Access, Inc. (1997)
- K923702: Intima Point Guard Intravascular Catheter, Becton Dickinson Vascular Access, Inc. (1993)

## Most influential descendants
- K141138: Surflash Safety I.V. Catheter (2014), 0 descendants of its own

## Indications for use
The SURFLASH Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shaft cover and tip shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy, The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi.

Source page: https://510kreport.com/device/K122544
Methodology: https://510kreport.com/methodology