Cleared Traditional

EZ-IO Intraosseous Vascular Access System

K202492 · Teleflex Medical · General Hospital
Mar 2021
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K202492 is an FDA 510(k) clearance for the EZ-IO Intraosseous Vascular Access System, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on March 22, 2021, 203 days after receiving the submission on August 31, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K202492 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2020
Decision Date March 22, 2021
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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