MobileAED, MobileALS, MobileAED+ and AdvantageAED
510(k) K092391
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092391 | Date1 Apr 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- Withdrawn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 MobileAED, MobileALS, MobileAED+, and AdvantageAED are automated external defibrillators (non-wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. These devices are intended for use by trained responders, including emergency medical services, first responders, and lay rescuers, to provide life-saving intervention during cardiac emergencies.
These defibrillators are supplied as reusable medical devices, intended for use in both pre-hospital and hospital settings. They are classified as Class III devices under FDA regulations (870.5310) and have received FDA 510(k) clearance through the traditional review pathway. The devices are not single-use and require proper maintenance, calibration, and periodic inspection to ensure reliable performance. No specific MRI safety information is provided, and storage conditions should adhere to manufacturer guidelines to preserve functionality.
Questions
AI-generated answers, 18 Sep 2026
Are these defibrillators suitable for use by untrained individuals, or are they specifically designed for trained responders only?
These devices—MobileAED, MobileALS, MobileAED+, and AdvantageAED—are explicitly designed for trained responders, including emergency medical services, first responders, and lay rescuers who have received proper training. While lay rescuers may use them in emergencies, their operation assumes prior instruction in CPR and defibrillation protocols to ensure safe and effective application during sudden cardiac arrest.
How are these defibrillators supplied, and do they require any special handling or maintenance?
The MobileAED, MobileALS, MobileAED+, and AdvantageAED are reusable devices, not single-use. They require regular maintenance, calibration, and periodic inspection to ensure reliable performance, as outlined in the manufacturer’s guidelines. Proper storage conditions are also critical to preserve functionality, though no specific MRI safety information is provided.
What regulatory pathway was followed for FDA clearance, and how does this affect their use in clinical settings?
These defibrillators received FDA 510(k) clearance through the traditional review pathway, classified as Class III devices under FDA regulations (870.5310). This means they underwent rigorous evaluation by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness. Their clearance does not imply any specific clinical indication beyond restoring normal heart rhythm in sudden cardiac arrest, but it confirms compliance with U.S. regulatory standards for automated external defibrillators.
Can these devices be used in both pre-hospital and hospital settings, or are they limited to one environment?
Yes, these defibrillators are explicitly designed for use in both pre-hospital and hospital settings. Their reusable nature and robust design make them suitable for emergency medical services, ambulances, and clinical environments where sudden cardiac arrest may occur.