Cleared Traditional

K231626 - OSPREY Closed IV Catheter System (OspreyV2)

K231626 is an FDA 510(k) clearance for OSPREY Closed IV Catheter System (OspreyV2), 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 90-day FDA review.

K231626 · Skydance Vascular, Inc. · General Hospital
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Aug 2023
Decision
90d
Days
Class 2
Risk

K231626 is an FDA 510(k) clearance for the OSPREY Closed IV Catheter System (OspreyV2). 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 August 31, 2023 after a review of 90 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 - K231626

510(k) Number K231626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2023
Decision Date August 31, 2023
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 K231626.
Nexiva™ Closed IV Catheter System with NearPort™ IV Access
K231239 · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 2023
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
K231401 · Poly Medicure Limited · Sep 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
K223788 · Medsource International, LLC · Sep 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
OSPREY PERIPHERAL IV Catheter System
K223018 · Skydance Vascular, Inc. · Apr 2023