Heartstream Xlt Defibrillator/Monitor, Ac Charger, Dc Charger, Data Card, Single Bay Adapter, Defibrillator Pads Cable

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

510(k) Number

K992543 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Is the Heartstream XLT defibrillator designed for single-use or reusable applications, and what modular components are included with it?

  The Heartstream XLT is a reusable defibrillator, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. It includes modular components such as an AC charger, DC charger, data card, a single bay adapter for defibrillator pads, and the defibrillator pads cable itself. These modular parts allow for flexibility in charging and data management while maintaining the core functionality of the device.

• What types of charging options does the Heartstream XLT defibrillator support, and how does this affect its portability?

  The Heartstream XLT supports both AC and DC charging, which enhances its versatility for use in various environments. The AC charger is suitable for stationary or fixed-location use, such as in emergency rooms or clinics, while the DC charger allows for portable operation in field settings, such as ambulances or disaster response scenarios. This dual-charging capability ensures the device remains operational regardless of power availability.

• How is the Heartstream XLT defibrillator regulated, and what classification does it fall under in the FDA system?

  The Heartstream XLT is regulated under the FDA’s classification III (K992543) and has received a 510(k) clearance, indicating it is deemed substantially equivalent to a legally marketed predicate device. It is governed by 21 CFR 870.5310, which outlines regulatory requirements for automated external defibrillators (non-wearable). This classification ensures rigorous oversight due to its critical role in emergency cardiac care.

• What storage and handling protocols should be followed for the Heartstream XLT defibrillator to ensure its reliability and longevity?

  The Heartstream XLT, being a reusable device, must adhere to standard medical device protocols for storage and handling, including proper cleaning, disinfection, and maintenance after each use. It should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality. The modular components, such as chargers and data cards, should also be stored securely to prevent damage, ensuring the device remains operational for emergency use when needed.

• Who is the intended user of the Heartstream XLT defibrillator, and what level of training is required?

  The Heartstream XLT is designed for use by trained emergency personnel, including those qualified in basic or advanced life support protocols. This ensures that operators have the necessary skills to assess cardiac rhythms, deliver defibrillation shocks, and follow resuscitation guidelines effectively. Proper training is critical to ensure safe and effective use in life-threatening cardiac emergencies.