Cleared Traditional

K180395 - EZ-IO Intraosseous Vascular Access System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180395 · Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · General Hospital
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 170d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. 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 - FMI Needle, Hypodermic, Single Lumen

All 29
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K180395.
Easydrip Classic Pen Needle
K252908 · Sandstone Medical (Suzhou), Inc. · Mar 2026
PRESSONE™
K253047 · Nipro Medical Corporation · Mar 2026
Safety Pen Needle
K253622 · Ningbo Medsun Medical Co., Ltd. · Mar 2026
Pen Needle
K252886 · Hh Global Technology, Inc. · Jan 2026
Pen Injector Needle 32.5
K250700 · Terumo Corporation · Nov 2025
Profoject™ Disposable Needle
K252631 · CMT Health PTE., Ltd. · Oct 2025