# K082362: Surshield Safety I.V. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Sep 17, 2008 after 30 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: 3 generations back to K801941 (1980). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891087: Terumo Surflo (R) I.V. Catheter, Terumo Medical Corp. (1989) Summary page 1.
- K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter, Terumo Medical Corp. (1999) Summary page 1.
- K020785: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K090973: Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes) (2009), 4 descendants of its own
- K100282: Terumo Surshield- Pur Safety I.V. Catheter (2010), 3 descendants of its own
- K122544: Terumo Surflash Safety I.V. Catheter (2012), 1 descendant of its own
- K141138: Surflash Safety I.V. Catheter (2014), 0 descendants of its own
- K123267: Surfflash (R) Plus Safety I.V. Catheter (2012), 0 descendants of its own

## Indications for use
The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle 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.

Source page: https://510kreport.com/device/K082362
Methodology: https://510kreport.com/methodology