Zoll X Series

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

510(k) Number

K133269 ↗

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 →

• Can the Zoll X Series be reused, or is it strictly single-use only?

  The Zoll X Series is designed for both single-use and reusable applications, depending on the specific model variant. The manufacturer’s documentation outlines usage guidelines for each variant, so check the accompanying technical manual to confirm the intended reuse or disposal for your particular unit.

• Is the Zoll X Series sterile, and if not, how should it be handled before use?

  The Zoll X Series is non-sterile as supplied. Since it is intended for emergency use in pre-hospital or public access settings, it should be handled with standard infection control precautions. The manufacturer’s instructions detail any pre-use cleaning or preparation steps required before deployment.

• What types of environments or settings is the Zoll X Series approved for, and does it have any special safety considerations?

  The Zoll X Series is approved for pre-hospital, emergency medical, and public access settings, including scenarios where sudden cardiac arrest may occur. It is designed with non-ferromagnetic components, ensuring compatibility with MRI environments if needed. However, its primary use remains in defibrillation and CPR support outside controlled MRI settings.

• How do I determine which model variant of the Zoll X Series I have, and does this affect its intended use?

  The Zoll X Series includes multiple model variants, each with specific usage instructions (single-use or reusable). The model variant is typically indicated on the device label or packaging. Refer to the accompanying technical documentation for storage, handling, and regulatory compliance details tied to your specific variant.

• What regulatory pathway was followed for the Zoll X Series, and which advisory committee was involved?

  The Zoll X Series underwent FDA 510(k) clearance (K133269) through the Cardiovascular (CV) Advisory Committee review process. This pathway confirms its substantial equivalence to a predicate device, ensuring compliance with FDA standards for automated external defibrillators (non-wearable).