Zoll AED Plus Version 5.32 Software Release
510(k) K091561
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091561 | Date23 Sep 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MKJ
- Device class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Zoll AED Plus Version 5.32 Software Release is an Automated External Defibrillator (Non-Wearable), designed to deliver life-saving electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. This device provides voice prompts, real-time feedback, and automated shock analysis to guide rescuers through cardiopulmonary resuscitation (CPR) and defibrillation procedures with minimal training required.
This software release is intended for use in pre-hospital, emergency response, and public-access settings, where trained or untrained responders may administer care. Supplied as a reusable device with replaceable components, it operates in environments where MRI safety is not a concern. The device requires proper training for operation and adheres to FDA 510(k) clearance under the classification of Class III medical devices, with a regulatory number of 870.5310. Storage and maintenance follow manufacturer guidelines to ensure functionality and reliability.
Other devices from Zoll Medical Corporation
Questions
AI-generated answers, 18 Sep 2026
What types of environments is the Zoll AED Plus Version 5.32 Software Release intended for use in, and who can operate it?
The Zoll AED Plus Version 5.32 Software Release is designed for pre-hospital, emergency response, and public-access settings where untrained or minimally trained responders may administer care. It is intended for use in environments where MRI safety is not a concern, meaning it should not be used near MRI machines or in areas requiring strict MRI compatibility. Proper training is required for operation, as the device provides voice prompts and real-time feedback to guide rescuers through CPR and defibrillation procedures.
Is the Zoll AED Plus Version 5.32 Software Release a single-use device, or can it be reused with replaceable components?
The Zoll AED Plus Version 5.32 Software Release is a reusable device, but it includes replaceable components to maintain functionality and reliability. This design allows for prolonged use in emergency response settings while ensuring that critical parts can be refreshed as needed.
What regulatory pathway was followed for the FDA clearance of this device, and what classification does it fall under?
The Zoll AED Plus Version 5.32 Software Release underwent a traditional 510(k) clearance process through the FDA, classified under the regulatory number 870.5310 as a Class III medical device. The clearance was determined to be substantially equivalent to a predicate device, and the review was conducted by the Cardiovascular (CV) Advisory Committee.
How should the device be stored and maintained to ensure proper functionality?
The Zoll AED Plus Version 5.32 Software Release requires adherence to the manufacturer’s guidelines for storage and maintenance. While specific instructions are not detailed in the provided data, typical best practices for reusable defibrillators—such as keeping the device in a clean, dry environment, protecting it from physical damage, and following scheduled maintenance protocols—should be followed to ensure reliability in emergency situations.