Zoll PAD
510(k) K011388
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011388 | Date25 Mar 2002 | StatusActive |
Recalls
-
- Terminated Z-0548-03
Defibrillator may fail to function due to false detection of safety fault condition
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- Withdrawn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, 20 Sep 2026
The Zoll PAD is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It is a portable, non-invasive device used to analyze heart rhythms and, when necessary, administer defibrillation therapy to treat ventricular fibrillation or pulseless ventricular tachycardia. The device is intended for use by trained responders, including emergency medical services (EMS) personnel and healthcare professionals.
The Zoll PAD is supplied as a single-use or reusable electrode system, depending on the specific pad model, and is intended for use with compatible Zoll defibrillators. It is not sterile and is not intended for direct implantation or invasive procedures. The device is classified as Class III under FDA regulations (870.5310) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Proper storage and handling are essential to maintain functionality, and the device must be used in accordance with manufacturer instructions and regulatory guidelines.