# K223018: OSPREY PERIPHERAL IV Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Skydance Vascular, Inc.
- Decided: Apr 14, 2023 after 197 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 K952861 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952861: Angiocath & Insyte Autoguard Catheters, Becton Dickinson Vascular Access, Inc. (1995) Summary page 4.

## Most influential descendants
- K231626: OSPREY Closed IV Catheter System (OspreyV2) (2023), 1 descendant of its own
- K250292: OSPREY Midline Closed IV Catheter System  (OspreyEDC-F20) (2025), 0 descendants of its own

## Indications for use
OSPREY PERIPHERAL IV catheter 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.

Source page: https://510kreport.com/device/K223018
Methodology: https://510kreport.com/methodology