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Ez-Mio Sternal

by Vidacare Corporation

510(k) K063567

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063567 Date26 Jan 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EZ-MIO STERNAL is a Class 2 General Hospital device with product code FMI. It is a hypodermic single-use device intended for sternal access.

The device is supplied sterile and is for single-use only. It is manufactured by Vidacare Corporation and cleared through the FDA 510(k) Traditional pathway under K063567.

Other devices from Vidacare Corporation

See all devices from Vidacare Corporation →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EZ-MIO STERNAL used for?

    The EZ-MIO STERNAL is intended for sternal access as a hypodermic single-use device in general hospital settings, designed to provide vascular or medication delivery through the sternum.

  • How is the EZ-MIO STERNAL supplied and is it reusable?

    The device is supplied sterile and is designated for single-use only; it must not be reprocessed or reused due to risks of contamination, material degradation, and compromised sterility after initial use.

  • What regulatory pathway cleared the EZ-MIO STERNAL?

    The EZ-MIO STERNAL received FDA 510(k) clearance through the Traditional pathway under submission number K063567, demonstrating substantial equivalence to a legally marketed predicate device.