510(k) Report

FDA applicant

Bio Protech, Inc.

Crofton, MD17 decisions2002–20190 recalls

FDA records 17 decisions for Bio Protech, Inc. (Crofton, MD) from 2002 to 2019: 17 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and GXY (Electrode, Cutaneous). Its devices cite 18 predicates, 1 of them its own earlier devices. 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, neurology panel, where it files most

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

FDA decisions per year

1in 2019

2007: 12008: 22009: 32010: 12011: 12014: 12015: 12016: 22019: 1
2007high 3 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio Protech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DRXElectrode, Electrocardiograph4decisions
  • GXYElectrode, Cutaneous4decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions
  • FYDApparatus, Exhaust, Surgical1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • IKTElectrode, Needle, Diagnostic Electromyograph1decision

Also: LIH (1), IPF (1).

Whose devices does it build on?

Its devices cite 18 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K020003Electrocardiograph (Ecg) Electrode, Non-SterileBio Protech, Inc. · 20022cite it
  • K040784Protab Ecg Tabb ElectrodeBio Protech, Inc. · 20041cites it
  • K111270Reusable Stimulating ElectrodesBio Protech, Inc. · 20111cites it
  • K142099Cutaneous ElectrodesBio Protech, Inc. · 20141cites it
  • K053011Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20Bio Protech, Inc. · 20051cites it
  • K092732Propencil Esu PencilBio Protech, Inc. · 20091cites it

What has FDA decided for it lately?

  • K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc. · 2019
  • K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle…Bio Protech, Inc. · 2016
  • K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesBio Protech, Inc. · 2016
  • K143103PROPENCIL Smoke PencilBio Protech, Inc. · 2015
  • K142099Cutaneous ElectrodesBio Protech, Inc. · 2014
  • K111270Reusable Stimulating ElectrodesBio Protech, Inc. · 2011
  • K100246MAX-IF1000Bio Protech, Inc. · 2010
  • K091248Maxems, Models 1000 and 2000Bio Protech, Inc. · 2009

All 17 as Bio Protech, Inc. →