Cleared Traditional

K250292 - OSPREY Midline Closed IV Catheter Syste...

K250292 is an FDA 510(k) clearance for OSPREY Midline Closed IV Catheter Syste..., manufactured by Skydance Vascular, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K250292 · Skydance Vascular, Inc. · General Hospital
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May 2025
Decision
91d
Days
Class 2
Risk

K250292 is an FDA 510(k) clearance for the OSPREY Midline Closed IV Catheter System (OspreyEDC-F20). Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Skydance Vascular, Inc. (Pleasant Grove, US). The FDA issued a Cleared decision on May 2, 2025 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Skydance Vascular, Inc. devices

FDA 510(k) Submission Details - K250292

510(k) Number K250292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2025
Decision Date May 02, 2025
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K250292.
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter
K251654 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2025
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector
K250682 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2025
Ruby Intravascular Catheter
K243105 · Venocare, Inc. · May 2025
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)
K244059 · Access Vascular, Inc. · Mar 2025
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
K243599 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Mar 2025
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620)
K242281 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Dec 2024