510(k) Report

FDA applicant

Medfusion, Inc.

Duluth, GA5 decisions1989–19910 recalls

FDA records 5 decisions for Medfusion, Inc. (Duluth, GA) from 1989 to 1991: 5 510(k) clearances. All are in product code FRN (Pump, Infusion). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Medfusion, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medfusion, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medfusion, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRNPump, Infusion5decisions

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K901755Model 3001 Syringe Infusion PumpMedfusion, Inc. · 19902cite it
  • K890120Syringe Infusion PumpMedfusion, Inc. · 19892cite it

What has FDA decided for it lately?

  • K905783Modified Walkmed 400Medfusion, Inc. · 1991
  • K905029Model 2001, ModificationMedfusion, Inc. · 1990
  • K901755Model 3001 Syringe Infusion PumpMedfusion, Inc. · 1990
  • K890862Ambulatory Infusion PumpMedfusion, Inc. · 1989
  • K890120Syringe Infusion PumpMedfusion, Inc. · 1989

All 5 as Medfusion, Inc. →