# K891087: Terumo Surflo (R) I.V. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jun 23, 1989 after 114 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter (1999), 9 descendants of its own
- 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

## Recalls of this device
- Aug 5, 2015 · Class II · Z-1896-2017: According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percen

Source page: https://510kreport.com/device/K891087
Methodology: https://510kreport.com/methodology