Heartstream Xl Defibrillator/Monitor, Model #m4735a
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K021453 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 HeartStart XL Defibrillator/Monitor (Model M4735A) is an automated external defibrillator designed for use by trained medical personnel in resuscitation efforts. It delivers synchronized cardioversion and defibrillation shocks to restore normal heart rhythm in patients experiencing cardiac arrest or life-threatening arrhythmias. The device also provides continuous ECG monitoring and advanced arrhythmia analysis to guide resuscitation protocols.
This device is intended for hospital use and is supplied as a reusable medical instrument. It operates in both defibrillation and monitoring modes, with features tailored for Advanced Cardiac Life Support (ACLS) protocols. The HeartStart XL has received FDA 510(k) clearance under the classification of Class III medical devices (K021453), adhering to regulatory standards for cardiovascular resuscitation equipment. It is not MRI-compatible and requires proper storage and maintenance as outlined in manufacturer guidelines.
Frequently asked questions
Is the HeartStream XL Defibrillator/Monitor intended for use outside of a hospital setting, such as in public places or by lay responders?
No, the HeartStream XL Defibrillator/Monitor (Model M4735A) is explicitly designed for hospital use only by trained medical personnel. Its features, including advanced arrhythmia analysis and ACLS protocols, are tailored for clinical resuscitation environments where healthcare professionals can administer synchronized cardioversion and defibrillation. Public or lay responder use is not supported or indicated.
How is the HeartStream XL Defibrillator/Monitor supplied, and is it single-use or reusable?
The HeartStream XL Defibrillator/Monitor (Model M4735A) is supplied as a reusable medical instrument, not a single-use device. As a reusable device, it requires proper maintenance, cleaning, and calibration per manufacturer guidelines to ensure reliable performance in resuscitation efforts. This aligns with its hospital-based use case, where durability and repeated use are essential.
Can this device be used in an MRI environment, or does it pose any risks?
The HeartStream XL Defibrillator/Monitor is not MRI-compatible. The device should not be used in or near an MRI environment due to potential interference or safety risks associated with electromagnetic fields. Always follow manufacturer storage and operational guidelines to avoid exposure to MRI environments.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The HeartStream XL Defibrillator/Monitor (Model M4735A) received FDA 510(k) clearance under the classification of Class III medical devices, with a decision code of *SESE* (Substantially Equivalent) for the Cardiovascular specialty. This means the device was determined to be substantially equivalent to a legally marketed predicate device in terms of technology and safety, ensuring it meets regulatory standards for cardiovascular resuscitation equipment. The clearance confirms its compliance for hospital use as described.
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. Sources consulted: Heartstream Xl Defibrillator/Monitor, Model #M4735a, PDF HEARTSTART XL - Philips, User manual Philips HeartStart XL M4735A (English - 304 pages), PHILIPS M4735A SERVICE MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021453 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (1)
- FDA 510(k) K021453 24 fields · synced Oct 6, 2026