Zoll AEDPro with 2010 AHA Guidelines Software Update
510(k) K110526
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110526 | Date25 Mar 2011 | StatusActive |
Official records
- FDA 510(k) database K110526
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- Withdrawn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 AEDPro 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. It provides voice prompts and visual guidance to assist untrained responders in performing cardiopulmonary resuscitation (CPR) and defibrillation, adhering to the 2010 American Heart Association (AHA) guidelines.
This device is intended for pre-hospital and public access use, supplied as a reusable medical device with a single-patient-use pad configuration. It is not MRI-safe and requires proper storage in a dry, temperature-controlled environment. The update aligns its software with the 2010 AHA resuscitation guidelines, and it holds FDA 510(k) clearance under the classification of Class III medical devices, regulated under 21 CFR 870.5310.