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Modified Walkmed 400

by Medfusion, Inc.

510(k) K905783

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 NumberK905783 Date11 Jan 1991ClearedStatusActive

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  • Withdrawn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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Modified Walkmed 400 is an infusion pump, classified as a Class II medical device under regulation number 880.5725. It is designed for general hospital use and has been determined to be substantially equivalent to a legally marketed device through the FDA 510(k) clearance process.

The device was cleared by the FDA on January 11, 1991, under K number K905783, with product code FRN. It is manufactured by Medfusion, Inc., and is not subject to third-party review. The clearance type is traditional, and the device is intended for use in general hospital settings.

Other devices from Medfusion, Inc.

Questions

AI-generated answers, 22 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 Modified Walkmed 400 used for?

    The Modified Walkmed 400 is an infusion pump designed for general hospital use, intended to deliver fluids, medications, or nutrients intravenously in clinical settings as part of standard patient care.

  • How was the Modified Walkmed 400 authorized for market release?

    The device received FDA 510(k) clearance on January 11, 1991, under K number K905783, demonstrating substantial equivalence to a legally marketed predicate device through the traditional review pathway.

  • Who manufactures the Modified Walkmed 400 and where is it made?

    The Modified Walkmed 400 is manufactured by Medfusion, Inc., with operations based in Duluth, Georgia, United States, as indicated in the device’s registration and authorization records.