# K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jun 16, 1999 after 55 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: 1 generation back to K891087 (1989). 2 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971339: Insyte, Insyte-W, Insyte Autoguard Catheters, Becton Dickinson Vascular Access, Inc. (1997) Summary page 3.
- K891087: Terumo Surflo (R) I.V. Catheter, Terumo Medical Corp. (1989) Summary page 2.

## Most influential descendants
- K082362: Surshield Safety I.V. Catheter (2008), 5 descendants of its own
- K090973: Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes) (2009), 4 descendants of its own
- K082997: Terumo Hybria Closed System Safety I.V. Catheter (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

## Indications for use
The TERUMO® SURFLO® FLEX L.V. Catheters and the TERUMO® SURFLASH™ 1.V. Catheters are devices consisting of a slender, flexible, radio-opaque, plastic catheter with a hub. The plastic catheter is inserted into the patient’s vascular system for short term use to withdraw samples, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula, placed in the catheter to maintain rigidity, is withdrawn after the catheter is placed in the vascular system.

Source page: https://510kreport.com/device/K991406
Methodology: https://510kreport.com/methodology