Life Support for Trauma and Transport
510(k) K965117
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)ST | NumberK965117 | Date26 Jun 1998 | 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- Withdrawn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
- ST
Overview
AI-generated summary, 18 Sep 2026
This device is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to the heart during cardiac arrest or arrhythmias in prehospital and transport settings. It provides automated analysis of heart rhythms and delivers synchronized or unsynchronized shocks to restore normal cardiac function, ensuring critical intervention during trauma or emergency transport scenarios.
The device is intended for single-use or reusable applications, depending on the specific model and configuration, and is classified as a Class III medical device under FDA regulations. It is supplied as a portable unit for use in emergency medical services, prehospital care, and transport environments, with no indication of MRI compatibility. Storage and handling follow standard medical device protocols, and its regulatory status includes FDA 510(k) clearance under the traditional review pathway with subject-to-tracking requirements.
Questions
AI-generated answers, 18 Sep 2026
Is this defibrillator designed for use in both emergency rooms and during patient transport, or is it specifically for prehospital settings only?
This device is explicitly designed for prehospital and transport settings, not for use in emergency rooms or clinical facilities. The name ‘Life Support for Trauma and Transport’ and its description emphasize its role in emergency medical services and transport environments, where immediate intervention is critical during cardiac arrest or arrhythmias outside of a hospital.
Can this defibrillator be reused after a single use, or is it strictly single-use only?
The device is intended for either single-use or reusable applications, depending on the specific model and configuration. The manufacturer does not specify reuse guidelines in the provided data, so users must consult the model-specific instructions to determine compatibility with reuse. Standard medical device protocols for cleaning and sterilization would apply if reuse is permitted.
What types of electrical shocks does this defibrillator deliver, and how does it determine when to administer them?
This Automated External Defibrillator (Non-Wearable) delivers both synchronized and unsynchronized shocks to restore normal cardiac function during cardiac arrest or arrhythmias. It includes an automated analysis system to detect heart rhythms, determining whether intervention is necessary and selecting the appropriate shock type based on the patient’s condition.
How is this device regulated by the FDA, and what does the ‘subject-to-tracking’ requirement mean for purchasers?
The device received FDA 510(k) clearance under the traditional review pathway and is classified as a Class III medical device, indicating it carries higher regulatory scrutiny. The ‘subject-to-tracking’ requirement means the FDA will monitor post-market performance data for this device to ensure continued safety and effectiveness, which may impact reporting obligations for purchasers or users.
Are there different models or sizes available for this defibrillator, or is it supplied as a single portable unit?
The data does not specify distinct sizes or models beyond the general description of a portable unit for prehospital and transport use. However, the presence of multiple FEI numbers (e.g., 3026976873, 1218058, etc.) suggests there may be variations in configurations or accessories. For exact model details, including sizes or features, refer to the manufacturer’s product catalog or model-specific documentation.