Pathfinder SL Holter Analyzer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110001 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pathfinder SL Holter Analyzer is a medical device classified as an ambulatory electrocardiogram (ECG) analyzer (Device Type: DQK). It is designed to process and analyze continuous cardiac rhythm recordings obtained from patients during routine daily activities, enabling the detection of arrhythmias and other cardiac abnormalities over extended periods.
This device is intended for use in clinical settings to review and interpret Holter monitor recordings from adult patients. Supplied as a reusable system, it requires no sterility assurance and is not MRI-safe. The analyzer includes advanced algorithms for arrhythmia detection and data editing, supporting comprehensive ECG analysis. Authorized under FDA 510(k) clearance and MDR, it adheres to regulatory standards for cardiovascular diagnostic devices.
Frequently asked questions
What types of cardiac abnormalities can the Pathfinder SL Holter Analyzer detect during its analysis of Holter monitor recordings?
The Pathfinder SL Holter Analyzer is designed to detect arrhythmias and other cardiac abnormalities by analyzing continuous ECG recordings over extended periods. Its advanced algorithms focus on identifying irregular heart rhythms, which are critical for diagnosing conditions like atrial fibrillation, ventricular tachycardia, or bradycardia. It is specifically intended for reviewing adult patient Holter monitor data in clinical settings.
Is the Pathfinder SL Holter Analyzer reusable, and if so, what does that mean for maintenance and cleaning?
Yes, the Pathfinder SL Holter Analyzer is supplied as a reusable system, meaning it is not intended for single-use. This implies that proper maintenance, cleaning, and sterilization (if applicable) are required between uses to ensure device integrity and patient safety. However, since it is not labeled as sterile, standard disinfection protocols for reusable medical devices should be followed.
How is the regulatory status of the Pathfinder SL Holter Analyzer defined, and what does this mean for healthcare providers?
The Pathfinder SL Holter Analyzer holds both FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for ambulatory ECG analyzers. This means healthcare providers can rely on its compliance with established safety and performance criteria for cardiovascular diagnostic devices, ensuring its use aligns with legal and clinical best practices.
Can the Pathfinder SL Holter Analyzer be used in an MRI environment, and why?
No, the Pathfinder SL Holter Analyzer is explicitly labeled as not MRI-safe. This means it should not be used or placed in an MRI environment, as exposure to magnetic fields could compromise its functionality or pose safety risks to patients or staff.
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: Pathfinder SL - Spacelabs Healthcare, Spacelabs Healthcare Pathfinder SL Operation Manual, Spacelabs Healthcare Pathfinder SL Operation Manual | Manualzz, Pathfinder SL Holter Analyzer 98000 « Products « Spacelabs Healthcare
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K110001 | Class II | Active |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare Ltd
- FDA Applicant
- Spacelabs Healthcare, Ltd.
Sources (2)
- FDA 510(k) K110001 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026