Identifiers
- 510(k) Number
- K941970 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fast-Patch is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It automatically analyzes heart rhythms and advises whether a shock is needed, making it accessible for use by trained and untrained responders in emergency situations.
Supplied as a reusable device, the Fast-Patch is intended for use in pre-hospital and emergency medical settings. It is not classified as MRI-safe and requires proper storage and maintenance as outlined in its operational manual. Authorized under FDA 510(k) clearance (K941970), it adheres to regulatory standards for cardiovascular devices under regulation number 870.5310.
Frequently asked questions
What types of emergency settings is the Fast-Patch intended for, and how does its design support untrained responders?
The Fast-Patch is specifically designed for pre-hospital and emergency medical settings, where immediate intervention is critical during sudden cardiac arrest. Its automated rhythm analysis and voice-guided instructions make it accessible to untrained responders by simplifying the process of determining whether a shock is needed, reducing the barrier to effective defibrillation in high-stress situations.
Is the Fast-Patch reusable, and what maintenance or storage requirements should be followed to ensure proper functionality?
Yes, the Fast-Patch is a reusable device, which means it must be maintained and stored according to the manufacturer’s operational manual to ensure reliability. Since it is not MRI-safe, it should be kept away from magnetic fields, and regular inspections or servicing may be required to uphold performance standards for emergency use.
How does the Fast-Patch’s regulatory pathway differ from other defibrillators, and what does the FDA 510(k) clearance indicate?
The Fast-Patch was cleared via the FDA’s 510(k) pathway, which demonstrates it is *substantially equivalent* to a legally marketed predecessor device under the same regulatory classification (Class III, cardiovascular). This clearance indicates the device meets FDA standards for safety and effectiveness as an automated external defibrillator (non-wearable), though it does not imply approval for specific clinical indications—only that it adheres to regulatory requirements for its intended use.
Are there different models or sizes available for the Fast-Patch, and how would a buyer determine the right fit for their needs?
The provided data does not specify distinct models or sizes for the Fast-Patch, but it is listed under the product code *MKJ* in the FDA registry, which may correspond to a standardized version for general emergency use. Buyers should confirm compatibility with their operational workflows (e.g., pre-hospital vs. in-facility) and consult Physio-Control’s documentation or support team to ensure the device aligns with their specific requirements, such as portability or integration with existing systems.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K941970 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Physio-Control Corp.
Sources (1)
- FDA 510(k) K941970 24 fields · synced Sep 18, 2026