510(k) Report

FDA applicant

Bio-Detek, Inc.

Pawtucket, RI17 decisions1985–20151 recall

FDA records 17 decisions for Bio-Detek, Inc. (Pawtucket, RI) from 1985 to 2015: 17 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and DRX (Electrode, Electrocardiograph). Its devices cite 8 predicates, 2 of them its own earlier devices. 1 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 Bio-Detek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2007: 12010: 12014: 12015: 2
2007high 2 (2015) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Bio-Detek, 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?

  • MKJAutomated External Defibrillators (Non-Wearable)10decisions
  • DRXElectrode, Electrocardiograph3decisions
  • LIXAid, Cardiopulmonary Resuscitation1decision
  • HAMApparatus, Electrosurgical1decision
  • GXYElectrode, Cutaneous1decision
  • GXZElectrode, Needle1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 2 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.

  • K071321PocketcprBio-Detek, Inc. · 20075cite it
  • K964213Trace Rite Solid Gel Ecg ElectrodesBio-Detek, Inc. · 19962cite it
  • K981802Zoll Stat*Padz Adult Multi-Function Electrodes Model Number 8900-4003Bio-Detek, Inc. · 19981cites it
  • K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc. · 20141cites it
  • K100565Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325Bio-Detek, Inc. · 20101cites it
  • K853291GP-100 Adult Electrosurgical Ground Pad/200 & 300Bio-Detek, Inc. · 19851cites it

What has FDA decided for it lately?

  • K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc. · 2015
  • K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc. · 2015
  • K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc. · 2014
  • K100565Dura Padz (Reusable Electrode), Dura Padz Gel (Disposable Hydrogel) Model 8900-0300, 8900-0325Bio-Detek, Inc. · 2010
  • K071321PocketcprBio-Detek, Inc. · 2007
  • K040256Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005Bio-Detek, Inc. · 2004
  • K040056Bio-Detek Electrode Adapter, Model R2001-90Bio-Detek, Inc. · 2004
  • K033771Bio-Detek Modified Adult Multi-Function Electrode with ConnectorBio-Detek, Inc. · 20041 recall

All 17 as Bio-Detek, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K033771Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak…Mar 12, 2013Class II