Model 43130A Defibrillator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853439 ↗

FDA Product Code

LDD

Device Class

Class II

Regulation

21 CFR Part 870.5300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Is the Model 43130A Defibrillator designed for single-use or reusable in clinical settings, and what maintenance is required?

  The Model 43130A Defibrillator is a reusable device intended for use in emergency medical settings, including pre-hospital and hospital environments. Since it is not single-use, it requires proper maintenance and calibration as outlined by the manufacturer to ensure reliable performance. Regular upkeep is essential to maintain its microprocessor-controlled functionality and safety for delivering controlled electrical shocks.

• What types of energy does the Model 43130A Defibrillator deliver, and how does it determine the appropriate shock level?

  The Model 43130A is a low-energy external defibrillator, meaning it delivers controlled electrical shocks tailored to restore normal heart rhythm in patients experiencing ventricular fibrillation or pulseless ventricular tachycardia. The device uses microprocessor-controlled technology to monitor the patient’s heart rhythm and determine the precise energy level required for each shock, ensuring targeted and effective treatment.

• What are the primary settings or environments where this defibrillator is intended to be used?

  This defibrillator is specifically designed for emergency medical use in both pre-hospital (e.g., ambulance) and hospital environments. Its classification as a Class II medical device under FDA regulations reflects its critical role in life-saving interventions for cardiac emergencies, particularly in settings where immediate defibrillation is required.

• How does the regulatory pathway for the Model 43130A Defibrillator differ from other defibrillators, and what does the SESE decision code indicate?

  The Model 43130A received FDA clearance through the traditional 510(k) review pathway with a decision code of SESE (Substantially Equivalent, Special Expert Panel). This indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, but its review required input from a specialized expert panel in the cardiovascular category (advisory committee: CV). This pathway ensures rigorous evaluation for safety and performance before clearance.

• Are there specific accessories or components (like paddles) required for use with this defibrillator, and how are they categorized?

  Yes, the Model 43130A Defibrillator operates with paddles or adhesive pads to deliver shocks. These accessories are included in the Low-Energy Defibrillator (LDD) product code category under FDA regulations, which groups devices designed for controlled electrical defibrillation. The device’s specifications align with this classification, ensuring compatibility with standard defibrillation accessories.