510(k) Report

FDA applicant

Medway

Franklin, TN5 decisions1991–19940 recalls

FDA records 5 decisions for Medway (Franklin, TN) from 1991 to 1994: 5 510(k) clearances. Most are in product codes KMI (Monitor, Bed Patient) and BYG (Mask, Oxygen). 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 Medway’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medway since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medway 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?

  • KMIMonitor, Bed Patient2decisions
  • BYGMask, Oxygen1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • KMKDevice, Intravascular Catheter Securement1decision

What has FDA decided for it lately?

All 5 as Medway →