Identifiers
- 510(k) Number
- K903918 FDA 510(k)
- FDA Product Code
- DRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2360 FDA 510(k)
- Regulation Number
- 870.2360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 1850 Electrode is a disposable electrocardiograph electrode designed for use in cardiovascular monitoring. It functions as an electrical conductor applied to the skin to detect and transmit cardiac electrical signals for analysis by electrocardiograph devices.
This electrode is supplied as a single-use, non-sterile device intended for use in clinical settings such as hospitals and cardiac care units. It is classified under FDA Product Code DRX and was granted FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent to the predicate device. No MRI safety or sterility requirements are specified in the regulatory data.
Frequently asked questions
What is the primary purpose of the Model 1850 Electrode in clinical settings?
The Model 1850 Electrode is designed specifically for cardiac monitoring by acting as an electrical conductor. It detects and transmits the heart’s electrical signals to an electrocardiograph (ECG) device for analysis, making it essential in environments like hospitals and cardiac care units where continuous or periodic ECG monitoring is required.
Is the Model 1850 Electrode reusable, or is it meant for single-use only?
The Model 1850 Electrode is explicitly labeled as a single-use device, meaning it is intended for one-time application per patient. This design minimizes infection risks and ensures consistent performance, aligning with clinical best practices for disposable medical devices.
How should the Model 1850 Electrode be stored, and are there any special handling requirements?
Since the electrode is non-sterile and disposable, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until use to maintain its integrity and functionality, as per standard practices for single-use medical devices.
What regulatory pathway was followed for FDA clearance of the Model 1850 Electrode?
The Model 1850 Electrode received FDA 510(k) clearance through the Traditional pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This classification falls under FDA Product Code DRX, and the submission was reviewed by the Cardiovascular (CV) Advisory Committee. The clearance was granted in 1990.
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: MODEL 1850 ELECTRODE (K903918) — FDA 510(k) | Innolitics, MODEL 1850 ELECTRODE (K903918) - FDA 510 (k), Model 1850 Electrode - Beudamed, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K903918 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K903918 24 fields · synced Sep 19, 2026