# K250292: OSPREY Midline Closed IV Catheter System  (OspreyEDC-F20)

- Pathway: 510(k) (Traditional)
- Applicant: Skydance Vascular, Inc.
- Decided: May 2, 2025 after 91 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 K032843 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231626: OSPREY Closed IV Catheter System (OspreyV2), Skydance Vascular, Inc. (2023) Summary page 5.

## Indications for use
OSPREY Midline Closed IV Catheter System (OspreyEDC) is an intravascular catheter intended to be inserted into the patient’s vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The OSPREY Midline Closed IV Catheter System (OspreyEDC) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.

Source page: https://510kreport.com/device/K250292
Methodology: https://510kreport.com/methodology