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Humeral Head Manual Driver

by Vidacare Corporation

510(k) K062422

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 NumberK062422 Date7 Nov 2006ClearedStatusActive

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  • Withdrawn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 Humeral Head Manual Driver is a manual intraosseous (IO) infusion system consisting of a pentagon shaft attached to an ergonomic handle. It is used by clinicians for emergency vascular access in the humeral head. The device facilitates manual insertion of a 15g x 25mm needle set (stylet and catheter) into the bone cortex.

Upon reaching the marrow, the manual driver is detached and the stylet is removed, leaving a standard catheter in place. The device is supplied as a single-use item and is classified under product code FMI as a Needle, Hypodermic, Single Lumen with Class II - Special Controls. It received FDA 510(k) clearance on November 7, 2006.

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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 Humeral Head Manual Driver used for?

    The Humeral Head Manual Driver is a manual intraosseous (IO) infusion system used by clinicians for emergency vascular access in the humeral head. It facilitates manual insertion of a 15g x 25mm needle set into the bone cortex.

  • How is the Humeral Head Manual Driver supplied?

    The device is supplied as a single-use item and consists of a pentagon shaft attached to an ergonomic handle. It is classified under product code FMI as a Needle, Hypodermic, Single Lumen with Class II - Special Controls.

  • Is the Humeral Head Manual Driver reusable?

    No, the Humeral Head Manual Driver is supplied as a single-use item. After reaching the marrow, the manual driver is detached and the stylet is removed, leaving a standard catheter in place.

  • What regulatory approval does the Humeral Head Manual Driver have?

    The Humeral Head Manual Driver received FDA 510(k) clearance on November 7, 2006. It is classified under product code FMI as a Needle, Hypodermic, Single Lumen with Class II - Special Controls.