External Pulse Generator EV4542

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K821791 ↗

FDA Product Code

DTE

Device Class

Class II

Regulation

21 CFR Part 870.3600

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from American Pacemaker Corp. →

• What is the primary purpose of the External Pulse Generator EV4542, and how does it differ from a permanent pacemaker?

  The External Pulse Generator EV4542 is designed to provide temporary cardiac pacing by delivering external electrical stimulation to the heart when its natural rhythm fails. Unlike a permanent pacemaker, which is implanted inside the body, this device is portable and meant for external use as a short-term solution. It acts as a substitute for the heart’s intrinsic pacing system during critical periods, such as post-surgery recovery or acute heart failure, until the patient’s natural rhythm stabilizes or a permanent device can be implanted.

• Is the EV4542 meant for single-use or can it be reused in clinical settings?

  The EV4542 is supplied as either a single-use or reusable system, depending on the clinical context. Since it is a temporary device, its reuse would depend on proper cleaning, maintenance, and adherence to facility protocols to ensure safety and functionality. There is no explicit sterility requirement mentioned, so reuse would require careful handling and validation by the healthcare provider to maintain efficacy and infection control.

• What regulatory pathway does the EV4542 follow, and what does that mean for its use in hospitals?

  The EV4542 follows the FDA 510(k) clearance pathway, specifically with clearance number K821791, and is classified as a Class II medical device under product code DTE. This means it has been determined to be substantially equivalent to a legally marketed device already on the market, ensuring it meets FDA safety and effectiveness standards. Hospitals can rely on this classification to confirm the device’s regulatory compliance before use.

• Are there specific storage requirements for the EV4542, and how should it be handled to maintain functionality?

  The provided data does not specify storage requirements for the EV4542, such as temperature or environmental conditions. However, as a medical device, it should be stored in a clean, dry place away from direct sunlight, extreme temperatures, or sources of electromagnetic interference. Proper handling—including avoiding physical damage and ensuring the device is powered off when not in use—is critical to maintaining its functionality and safety.

• What types of clinical scenarios would typically require the use of this external pulse generator?

  The EV4542 is intended for temporary cardiac pacing scenarios where the heart’s natural rhythm is compromised, such as during acute myocardial infarction, post-cardiac surgery recovery, or in cases of bradycardia where a permanent pacemaker is not immediately feasible. It bridges the gap until the patient’s condition stabilizes or a permanent solution can be implemented, providing critical support to maintain proper heart rhythm externally.