Cleared Traditional

K223018 - OSPREY PERIPHERAL IV Catheter System

K223018 is an FDA 510(k) clearance for OSPREY PERIPHERAL IV Catheter System, 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 197-day FDA review.

K223018 · Skydance Vascular, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
197d
Days
Class 2
Risk

K223018 is an FDA 510(k) clearance for the OSPREY PERIPHERAL IV Catheter System. 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 April 14, 2023 after a review of 197 days - an extended review cycle.

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 - K223018

510(k) Number K223018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date April 14, 2023
Days to Decision 197 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
68d slower than avg
Panel avg: 129d · This submission: 197d
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 K223018.
OSPREY Closed IV Catheter System (OspreyV2)
K231626 · Skydance Vascular, Inc. · Aug 2023
Mais Central Venous Catheter
K221827 · Saudi Mais Co. For Medical Products · Jun 2023
Polyguard and Polyshield Safety IV Catheters
K230616 · Poly Medicure Limited · May 2023
Cook® Spectrum® 2 MRC Central Venous Catheter
K223648 · Cook Advanced Technologies · Feb 2023
HydroMID 4F Single Lumen Midline Catheter
K220772 · Access Vascular, Inc. · Dec 2022
MagiCath II
K210929 · Woo Young Medical Co., Ltd. · Sep 2022