Padpro System Defibrillator Electrode Adapters

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

510(k) Number

K003548 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Padpro Model 2502

  Class III

  FDA 510(k) K020743 Active Cleared 28 May 2002

• PadPro Model 2603

  Class III

  FDA 510(k) K020288 Active Cleared 27 Feb 2002

• Padpro Model 2001, 2001-S, 2001-C, 2001-EPS

  Class III

  FDA 510(k) K014209 Active Cleared 18 Jan 2002

• PadPro Model 2516

  Class III

  FDA 510(k) K020203 Active Cleared 8 May 2002

• Are these adapters reusable or single-use, and why does that matter in emergency settings?

  The Padpro System Defibrillator Electrode Adapters are designed as single-use components. This is critical in emergency settings because single-use devices minimize the risk of cross-contamination between patients, ensuring hygiene and safety during resuscitation efforts. Reusing medical devices in cardiac arrest scenarios could introduce pathogens or compromise electrical conductivity, potentially delaying or failing shock delivery when every second counts.

• How do I know if these adapters will work with my defibrillator model, and what should I do if they’re not listed?

  Compatibility is verified with specific defibrillator models listed in the registration data (e.g., FEI numbers like 3026976873, 1218058, etc.). If your model isn’t listed, check the manufacturer’s documentation or contact Padpro, LLC directly (via Daniel Kamm at the provided address) for confirmation. Using incompatible adapters could result in poor electrical conductivity or failure to deliver a shock, risking patient safety during resuscitation.

• Are these adapters sterile, and if not, how should they be handled to maintain safety in clinical or pre-hospital use?

  The adapters are non-sterile and intended for single-use in pre-hospital or clinical settings where defibrillation is required. Since they’re not sterile, proper handling includes avoiding contact with contaminated surfaces or fluids before use. Always follow manufacturer guidelines for storage and use, ensuring they remain clean and dry until deployment to prevent degradation or contamination that could interfere with functionality.

• What storage instructions should I follow to keep these adapters functional until use?

  While exact storage instructions aren’t detailed in the data, the manufacturer recommends adhering to general guidelines for Class III medical devices to maintain functionality. Typically, this includes storing adapters in a cool, dry place, away from direct sunlight or extreme temperatures, and protecting them from physical damage. Avoid exposing them to moisture or chemicals, as these could compromise electrical conductivity or structural integrity before use.

• Why are these adapters classified as Class III devices, and what does that mean for their use in healthcare settings?

  These adapters are classified as Class III under FDA regulations (870.5310) because they support life-sustaining or life-supporting functions—specifically, ensuring reliable shock delivery during defibrillation. Class III classification requires stringent oversight, including a traditional 510(k) clearance process reviewed by the FDA’s Cardiovascular Advisory Committee. This ensures they meet rigorous safety and performance standards before use in pre-hospital or clinical settings where cardiac arrest outcomes depend on accurate and timely defibrillation.