510(k) Report

FDA applicant

Regional Master Corp.

Miami, FL4 decisions1986–19860 recalls

FDA records 4 decisions for Regional Master Corp. (Miami, FL) in 1986: 4 510(k) clearances. Most are in product codes BXN (Stimulator, Nerve, Battery-Powered) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). 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, anesthesiology panel, where it files most

How often FDA has decided Regional Master Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Regional Master Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Regional Master Corp. 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?

  • BXNStimulator, Nerve, Battery-Powered3decisions
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)1decision

What has FDA decided for it lately?

  • K853478Pinpoint NeedleRegional Master Corp. · 1986
  • K853422The GripperRegional Master Corp. · 1986
  • K853477Nerve FinderRegional Master Corp. · 1986
  • K853476T4 Monitor Stimulator ComputerRegional Master Corp. · 1986

All 4 as Regional Master Corp. →

Other applicant names beginning “Regional”

FDA records each applicant name separately; these may or may not be the same firm.

Regional Media Laboratories 2