# K082997: Terumo Hybria Closed System Safety I.V. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Apr 15, 2009 after 189 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 K891087 (1989). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter, Terumo Medical Corp. (1999) Summary page 1.
- K923702: Intima Point Guard Intravascular Catheter, Becton Dickinson Vascular Access, Inc. (1993) Summary page 1.
- K032843: Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- 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 Hybria Closed System Safety LV. 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 shield feature and the needleless access port 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/K082997
Methodology: https://510kreport.com/methodology