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Drug Access Spike

by Medegen Medical Manufacturing Services

510(k) K051930

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 NumberK051930 Date16 Aug 2005ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

A Drug Access Spike is a device designed for accessing medication from a vial or container, typically used in conjunction with a syringe to facilitate drug transfer or reconstitution. It is classified under the product code FMF and regulation 880.5860 as a Syringe, Piston type device intended for general hospital use.

The device was submitted as a traditional 510(k) by Medegen Medical Manufacturing Services and received FDA clearance on August 16, 2005, under K051930, with a decision of substantially equivalent (SESE). It is supplied as a non-sterile, single-use device and is intended for use in general hospital settings, with no claims of MRI safety or reusability indicated in the provided data.

Other devices from Medegen Medical Manufacturing Services, Inc.

Questions

AI-generated answers, 21 Sep 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 Drug Access Spike used for?

    The Drug Access Spike is designed to access medication from a vial or container, facilitating drug transfer or reconstitution when used with a syringe in general hospital settings.

  • Is the Drug Access Spike sterile or non-sterile, and is it intended for single use or reuse?

    The device is supplied as non-sterile and is intended for single-use only, with no indication of reusability in the provided data.

  • What regulatory pathway was used for the Drug Access Spike, and when was it cleared?

    The Drug Access Spike was submitted as a traditional 510(k) and received FDA clearance on August 16, 2005, under K051930, with a decision of substantially equivalent.