Bio-Detek Electrode Adapter, Model R2001-90

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040056 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bio-Detek Modified Adult Multi-Function Electrode with Connector

  Class III

  FDA 510(k) K033771 Active Cleared 27 Feb 2004

• RT40 Radio Translucent

  Class II

  FDA 510(k) K912714 Active Cleared 25 Jul 1991

• Zoll First Responder Padz Adult Defibrillation Electrodes

  Class III

  FDA 510(k) K990106 Active Cleared 26 Feb 1999

• Zoll Stat*padz Adult Multi-Function Electrodes Model Number 8900-4003

  Class III

  FDA 510(k) K981802 Active Cleared 25 Nov 1998

• DE12 Rapid Trace at-Rest Diagnostic ECG Electrodes

  Class II

  FDA 510(k) K853038 Active Cleared 7 Jan 1986

• Bio-Detek Tracerite EEG Electrode

  Class II

  FDA 510(k) K920264 Active Cleared 2 Jun 1992

See all devices from Bio-Detek, Inc. →

• Is the Bio-Detek Electrode Adapter, Model R2001-90, intended for single-use or reusable applications in clinical settings?

  The Bio-Detek Electrode Adapter, Model R2001-90, is explicitly described as a reusable medical device in the regulatory data. While the documentation does not specify its sterility status or cleaning instructions, its classification as reusable suggests it is designed for repeated use in clinical environments where defibrillation is required, provided proper maintenance and cleaning protocols are followed.

• What types of Automated External Defibrillators (Non-Wearable) is this adapter compatible with, and how does it enhance performance?

  The adapter is engineered as an interface component specifically for Non-Wearable Automated External Defibrillators (AEDs). It ensures proper electrical conduction between defibrillator pads and the AED unit, improving compatibility and performance during cardiac resuscitation. The regulatory data lists it under the product code MKJ, which aligns with AED-related devices, though exact model compatibility should be verified with the manufacturer.

• How is the Bio-Detek Electrode Adapter, Model R2001-90, regulated, and what does its FDA clearance status entail?

  The adapter holds FDA 510(k) clearance (K040056) under the Traditional 510(k) Review pathway, classified as substantially equivalent to a predicate device. It adheres to 21 CFR 870.5310 and was reviewed by the Cardiovascular (CV) Advisory Committee. This clearance indicates it meets FDA standards for safety and effectiveness as an interface component for Non-Wearable AEDs, though clinical use should align with the manufacturer’s instructions.

• Are there any special considerations for storage or handling of the Bio-Detek Electrode Adapter, Model R2001-90?

  The regulatory documentation does not provide explicit storage or handling instructions for the adapter. Since it is reusable, proper cleaning, disinfection, and maintenance procedures—consistent with medical device reprocessing guidelines—are critical to ensure functionality and safety. Users should consult the manufacturer’s guidelines for specific protocols, as these are not detailed in the submitted data.