Zoll Aed Plus with 2010 Aha Guidlines Software Update

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

510(k) Number

K110154 ↗

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 →

• Is this software update designed for use with existing Zoll AED Plus units, or does it require a new device purchase?

  This software update is specifically designed for existing Zoll AED Plus units and is not intended for standalone use. It is supplied as an upgrade to align the device’s functionality with the 2010 AHA resuscitation guidelines, ensuring compatibility only with the original hardware.

• How is the sterility of the Zoll AED Plus with the 2010 AHA Guidelines Software Update ensured?

  The software update itself does not introduce new sterility requirements beyond those of the original Zoll AED Plus device. Since it is a software update for an existing unit, sterility is maintained through the original device’s packaging and handling procedures, as no additional physical components are added.

• What type of regulatory clearance does this software update hold, and what does that mean for its use?

  The Zoll AED Plus with the 2010 AHA Guidelines Software Update holds FDA 510(k) clearance (K110154) under a special classification, meaning it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms the update’s compliance with U.S. regulatory standards for automated external defibrillators, ensuring it can be legally used in emergency cardiac care settings.

• Is the Zoll AED Plus with the 2010 AHA Guidelines Software Update intended for single-use or repeated use in emergency scenarios?

  The software update is intended for single-use applications in emergency response settings, aligning with the original Zoll AED Plus’s design. While the device itself may be reusable for multiple cardiac arrest events, the software update is provided as a one-time upgrade to ensure adherence to the 2010 AHA guidelines during its use.