HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR - Monitor.model M2500b
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K010634 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
- Models / Variants
- M4735a FDA 510(k)Heartstream Xlt Defibrillator FDA 510(k)Monitor.model M2500b 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 HeartStream XL and XLT Defibrillator/Monitors are automated external defibrillators designed for non-wearable use. These devices deliver synchronized and unsynchronized electrical shocks to restore normal heart rhythm in patients experiencing cardiac arrest, while continuously monitoring heart rate, rhythm, and other vital parameters for real-time assessment.
These devices are intended for use in pre-hospital, clinical, and public-access settings. Supplied as reusable medical equipment, they require proper training for operation and maintenance. The HeartStream XL and XLT are classified as Class III devices under FDA regulations and have received 510(k) clearance. They are not MRI-compatible and must be stored in a clean, dry environment as per manufacturer guidelines.
Frequently asked questions
Are the HeartStream XL and XLT defibrillators suitable for use in environments where MRI machines are present, and if not, why not?
No, the HeartStream XL (Model M4735A) and XLT (Model M2500B) defibrillators are explicitly stated as not MRI-compatible. This means they should not be used near MRI machines, as the electromagnetic fields generated by MRI could interfere with the device’s operation or pose safety risks to patients and operators.
What types of settings can these defibrillators be used in, and what training is required for their operation?
The HeartStream XL and XLT are designed for pre-hospital, clinical, and public-access settings, such as ambulances, hospitals, and public spaces like airports or shopping centers. Since they are reusable medical devices, proper training is required for both operation and maintenance to ensure safe and effective use in emergency cardiac arrest situations.
How should these defibrillators be stored, and what environmental conditions are necessary to maintain their functionality?
The manufacturer recommends storing the HeartStream XL and XLT in a clean, dry environment to preserve their functionality. Avoiding moisture, extreme temperatures, or dust exposure helps prevent damage and ensures reliable performance when needed for emergency cardiac interventions.
Are these devices single-use or reusable, and what does that mean for maintenance and replacement cycles?
The HeartStream XL and XLT are reusable medical devices, meaning they are designed for repeated use after proper cleaning, maintenance, and calibration. This requires adherence to manufacturer guidelines for servicing and periodic inspections to ensure they remain functional and safe for emergency cardiac defibrillation.
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 | K010634 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA 510(k) K010634 24 fields · synced Oct 6, 2026