510(k) Report

FDA applicant

R.E. Brown Co., Inc.

Mchenry, IL10 decisions1978–19780 recalls

FDA records 10 decisions for R.E. Brown Co., Inc. (Mchenry, IL) in 1978: 10 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and DTD (Pacemaker Lead Adaptor). 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, cardiovascular panel, where it files most

How often FDA has decided R.E. Brown Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R.E. Brown Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R.E. Brown Co., 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?

  • DTBPermanent Pacemaker Electrode6decisions
  • DTDPacemaker Lead Adaptor3decisions
  • DXYImplantable Pacemaker Pulse-Generator1decision

What has FDA decided for it lately?

  • K781624Pacing Lead Model Bus 860, Bus 890R.E. Brown Co., Inc. · 1978
  • K781622Pacing Lead Adapter Model Acs 16R.E. Brown Co., Inc. · 1978
  • K781621Pacing Lead Models, Mam 1260 Mam 1290R.E. Brown Co., Inc. · 1978
  • K781623Pacing Models Mum 860, Mum 890R.E. Brown Co., Inc. · 1978
  • K781619Pacing Lead Models SA, 350, Sam 500R.E. Brown Co., Inc. · 1978
  • K781625Pacing Lead Model MVM 860, MVM 890R.E. Brown Co., Inc. · 1978
  • K781620Pacing Lead Models, MDM 1060, MDM 1090R.E. Brown Co., Inc. · 1978
  • K781626Pacing Lead Adapter, Acv 14, Acv 23R.E. Brown Co., Inc. · 1978

All 10 as R.E. Brown Co., Inc. →