Cleared Special

K231924 - EZ-IO Intraosseous Vascular Access System

K231924 is an FDA 510(k) clearance for EZ-IO Intraosseous Vascular Access System, manufactured by Teleflex Medical. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 25-day FDA review.

K231924 · Teleflex Medical · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
25d
Days
Class 2
Risk

K231924 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 Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on July 25, 2023 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K231924

510(k) Number K231924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2023
Decision Date July 25, 2023
Days to Decision 25 days
Submission Type Special
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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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. 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 694
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K231924.
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K231924 · EZ-IO Intraosseous Vascular Access System
Download PDF FDA Summary Teleflex Medical