Disposable ECG Leadwires
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182327 FDA 510(k)
- FDA Product Code
- DSA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2900 FDA 510(k)
- Regulation Number
- 870.2900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Disposable ECG Leadwires are classified as Cable, Transducer and Electrode, Patient (Including Connector). These single-use devices facilitate electrocardiogram (ECG) monitoring by transmitting electrical signals from electrodes placed on a patient’s chest to an ECG machine, enabling real-time cardiac activity assessment.
Designed for disposable use, these leadwires are intended for clinical settings such as hospitals, cardiac care units, and emergency departments. Supplied sterile and packaged individually, they comply with FDA 510K clearance and MDR requirements. Multiple reference codes (e.g., 1018233, 3038181770) identify compatible configurations, including various cable lengths and connector types, ensuring compatibility with standard ECG systems. Storage instructions specify protection from moisture and physical damage.
Frequently asked questions
Are these leadwires reusable or designed for single-use only, and how does that affect their clinical use?
These leadwires are explicitly designed for single-use only, as stated in the description. This design ensures patient safety by eliminating the risk of cross-contamination between uses, which is critical in clinical settings like hospitals, cardiac care units, and emergency departments. Single-use also simplifies inventory management and reduces the need for sterilization between patients.
How should I store these leadwires to maintain their integrity and sterility before use?
The leadwires must be stored protected from moisture and physical damage to preserve their sterility and functionality. Since they are supplied sterile and packaged individually, ensure the packaging remains intact until use. Avoid exposing them to extreme temperatures, humidity, or direct sunlight, as these conditions could compromise their performance or sterility.
What types of ECG machines are compatible with these leadwires, and how do I know which model or length to choose?
These leadwires are designed to be compatible with standard ECG systems, as indicated by the multiple reference codes (e.g., 1018233, 3038181770) listed in the specifications. The compatibility includes various cable lengths and connector types, which are tailored to different ECG machine configurations. Check your ECG device’s documentation or consult the manufacturer’s guidelines to confirm the exact model, length, and connector type required for your setup.
Are these leadwires sterile when packaged, and if so, what precautions should I take when handling them?
Yes, these leadwires are supplied sterile and packaged individually for clinical use. To maintain sterility during handling, avoid touching the connector ends or the areas that will make contact with the patient. Use sterile gloves when preparing the leadwires for use, and ensure the packaging remains unopened until immediately before application. Once opened, use them promptly to prevent contamination.
What regulatory pathways have these leadwires undergone, and what does that mean for their use in clinical settings?
These leadwires have undergone FDA 510(k) clearance and comply with MDR (Medical Device Regulation) requirements, as noted in the authorizations. This means they have been evaluated for safety and performance by regulatory bodies, ensuring they meet established standards for use in clinical settings like hospitals and cardiac care units. The clearance does not specify a particular clinical indication but confirms their suitability for transmitting ECG signals as intended.
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 (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 | K182327 | Class II | Active |
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Manufacturer
- Manufacturer
- Orantech Inc.
- FDA Applicant
- Orantech, Inc.
Sources (2)
- FDA 510(k) K182327 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026