Zoll E Series with 2010 Aha Guidlines Software Update

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

510(k) Number

K110168 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Propaq MD

  Class III

  FDA 510(k) K112761 Active Cleared 25 Apr 2012

• Zoll Propaq Md

  Class II

  FDA 510(k) K102468 Active Cleared 30 Sep 2010

• Zoll E Series with CPRReadyCharge

  Class III

  FDA 510(k) K091265 Active Cleared 23 Dec 2009

• Zoll E Series Defibrillator

  Class III

  FDA 510(k) K072923 Active Cleared 24 Apr 2008

• Zoll E Series with Bluetooth Dial Up Networking

  Class III

  FDA 510(k) K081081 Active Cleared 9 Mar 2009

• Zoll R Series with 2010 Aha Guidelines Software Update

  Class III

  FDA 510(k) K110361 Active Cleared 8 Mar 2011

See all devices from Zoll Medical Corporation, World Wide Headquarters →

• What is the primary purpose of the Zoll E Series with the 2010 AHA Guidelines Software Update, and where is it typically used?

  The Zoll E Series is an Automated External Defibrillator (Non-Wearable) designed to deliver life-saving electrical shocks to restore a normal heart rhythm during sudden cardiac arrest. It uses advanced algorithms and real-time analysis to assess heart rhythms and guide interventions like defibrillation, pacing, and CPR guidance, following the 2010 American Heart Association (AHA) guidelines. It is intended for use in both pre-hospital (e.g., emergency medical services) and in-hospital settings by trained responders, including EMS personnel and healthcare professionals.

• Is the Zoll E Series a single-use device, or can it be reused after use?

  The Zoll E Series is a reusable medical device. It requires proper maintenance, calibration, and periodic software updates to ensure accurate performance and functionality. Unlike single-use devices, it is designed for repeated use in clinical settings, provided it is serviced according to manufacturer instructions.

• How does the Zoll E Series ensure compliance with regulatory standards, and what type of clearance does it hold?

  The Zoll E Series holds FDA 510(k) clearance (K110168) as substantially equivalent to a predicate device, confirming it meets regulatory requirements for safety and effectiveness. It is classified as a Class III device under FDA regulations, indicating it is subject to stringent oversight due to its critical role in life-saving interventions. Compliance is maintained through adherence to manufacturer guidelines for storage, handling, and periodic updates.

• What kind of storage and handling instructions should be followed to maintain the device’s functionality and sterility?

  The Zoll E Series requires storage and handling that strictly comply with the manufacturer’s instructions to preserve its functionality and ensure reliability. While the device itself is reusable and not sterile (as it is not a single-use consumable), proper maintenance, calibration, and environmental conditions must be maintained to prevent degradation. Manufacturer guidelines likely include temperature control, protection from physical damage, and regular servicing to uphold performance standards.

• What software updates are included with this device, and why are they important?

  The Zoll E Series includes a software update aligned with the 2010 AHA Guidelines, which ensures the device’s algorithms and interventions (such as defibrillation, pacing, and CPR guidance) remain current with evidence-based clinical practices. These updates are critical because they improve accuracy, reliability, and adherence to the latest resuscitation protocols, directly impacting patient outcomes during cardiac emergencies.