# K252398: SURFLO Hybria Closed System Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
- Decided: Dec 17, 2025 after 139 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 K032843 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102520: BD Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2011) Summary page 6.

## Indications for use
SURFLO Hybria Closed System Safety IV Catheter is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. The device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. When the device is used with a power injector, the needle-free connector should be removed, and the maximum pressure limit is 325 psi (2.24MPa).

Source page: https://510kreport.com/device/K252398
Methodology: https://510kreport.com/methodology