Zoll X Series
510(k) K133484
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133484 | Date1 Aug 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- Withdrawn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 Monitor/Defibrillator is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It combines defibrillation capabilities with advanced monitoring features, including real-time cardiac rhythm analysis and ECG waveform display to assist in assessing and treating cardiac emergencies.
This device is intended for use in pre-hospital and clinical settings by trained healthcare providers, including emergency medical services (EMS) personnel. Supplied as a reusable medical device, the X Series is regulated under FDA 510(k) clearance (K133484) and falls under device class III (870.5310). It is not single-use and requires proper maintenance, calibration, and storage as per manufacturer guidelines to ensure reliable performance.