ZOLL X Series
by Zoll Medical Corporation 2 variants
510(k) K142915
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142915 | Date3 Dec 2014 | 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- Withdrawn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 X Series 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, real-time ECG analysis, and biphasic waveform defibrillation to optimize resuscitation efforts in both pre-hospital and in-hospital settings.
This device is intended for single-use and is supplied as a reusable system with replaceable electrodes and batteries. It is classified as a Class III medical device under FDA regulations (870.5310) and has received FDA 510K clearance as substantially equivalent to predicate devices. The X Series is compatible with standard defibrillator pads and is intended for use by trained personnel in emergency response scenarios, adhering to strict regulatory and safety standards.
Other devices from Zoll Medical Corporation
Questions
AI-generated answers, 18 Sep 2026
Is the Zoll X Series designed for use in both pre-hospital and hospital settings, and what features make it suitable for these environments?
Yes, the Zoll X Series is explicitly designed for use in both pre-hospital and in-hospital settings. Its suitability stems from features like voice prompts for clear, step-by-step guidance, real-time ECG analysis to assess heart rhythm, and biphasic waveform defibrillation, which optimizes shock effectiveness. These capabilities ensure reliable performance in emergency scenarios where quick, accurate intervention is critical.
Are the electrodes and batteries for the Zoll X Series reusable or single-use, and how does this affect maintenance?
The Zoll X Series itself is a reusable system, but it is intended for single-use in terms of its consumables—specifically, the electrodes and batteries are replaceable. This design allows for cost-effective use over time, as the core device can be reused while only the disposable components (electrodes and batteries) are replaced after each procedure, reducing maintenance burden.
What compatibility does the Zoll X Series have with standard defibrillator pads, and does this affect its versatility?
The Zoll X Series is designed to be compatible with standard defibrillator pads, meaning it can utilize widely available electrodes from other manufacturers. This compatibility enhances its versatility, allowing users to source pads from multiple suppliers without needing to stock exclusive accessories, which can be particularly useful in diverse or resource-limited settings.
How does the Zoll X Series ensure safety and reliability in emergency cardiac arrest scenarios?
The Zoll X Series incorporates several safety and reliability features, including automated real-time ECG analysis to determine if a shock is needed, voice prompts to guide users through resuscitation steps, and biphasic waveform defibrillation, which delivers more effective shocks compared to monophasic waveforms. These features collectively reduce human error and improve the likelihood of restoring a normal heart rhythm during sudden cardiac arrest.