Cleared Traditional

K180395 - EZ-IO Intraosseous Vascular Access System

K180395 is an FDA 510(k) clearance for EZ-IO Intraosseous Vascular Access System, manufactured by Arrow International, Inc. (Subsidiary of Teleflex, Inc.). The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K180395 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
269d
Days
Class 2
Risk

K180395 is an FDA 510(k) clearance for the EZ-IO Intraosseous Vascular Access System. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (Reading, US). The FDA issued a Cleared decision on November 9, 2018 after a review of 269 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) devices

FDA 510(k) Submission Details - K180395

510(k) Number K180395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2018
Decision Date November 09, 2018
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General Hospital devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01866475 Completed Interventional Industry-sponsored

Continuous Intraosseous Vascular Access Over 48 Hours

A Study to Determine the Safety of Continuous Intraosseous Vascular Access Over a Period of 48 Hours

127
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Intraosseous Vascular Access
Study design Parallel
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Principal investigator Emanuel DeNoia, MD
Sponsor Vidacare Corporation (industry)
Started 2014-11-01 → Primary completion 2016-07-01
Primary outcome
Serious Complications From Intraosseous (IO) Access
View full study on ClinicalTrials.gov

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 263
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K180395.
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