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Adapter Cable

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050884

by Remington Medical, Inc.

Identifiers

510(k) Number
K050884 FDA 510(k)
FDA Product Code
DTA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3720 FDA 510(k)
Regulation Number
870.3720 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Adapter Cable is a Tester, Pacemaker Electrode Function device, classified under Device Class II in the U.S. regulatory framework. It serves as an intermediary connector to facilitate compatibility between pacing systems, temporary pacemakers, or surgical cable adapters and associated diagnostic or monitoring equipment, ensuring proper signal transmission for cardiovascular assessments.

This device is supplied as a disposable medical accessory, designed for single-use applications in clinical settings. It is intended for use with pacing system analyzers and temporary pacemaker systems, adhering to FDA 510(k) clearance under the Cardiovascular advisory committee. The 12-foot length (e.g., model ADAP-2000-12) is standardized for ease of integration with existing medical infrastructure, with no MRI safety restrictions specified. Storage and handling follow standard sterile or non-sterile medical device protocols as dictated by procedural guidelines.

Frequently asked questions

What is the Adapter Cable used for in clinical settings and how does it integrate with existing medical equipment?

The Adapter Cable acts as a connector to ensure compatibility between pacing systems, temporary pacemakers, or surgical cable adapters and diagnostic/monitoring devices. It facilitates proper signal transmission for cardiovascular assessments, allowing seamless integration with pacing system analyzers and temporary pacemaker systems. Its standardized 12-foot length (e.g., model ADAP-2000-12) is designed to fit into existing clinical workflows without requiring additional modifications.

Is the Adapter Cable intended for single-use or reusable applications, and how should it be handled?

The Adapter Cable is explicitly designed for single-use in clinical settings, as stated in its description. Since it is a disposable accessory, it must be handled according to standard sterile or non-sterile medical device protocols—following institutional guidelines for disposal after use to prevent contamination or reuse.

What are the key specifications or models available for the Adapter Cable, and how does its length factor into its use?

The primary model mentioned is the ADAP-2000-12, which features a 12-foot length to provide flexibility in clinical environments. This length ensures ease of integration with existing medical infrastructure, allowing clinicians to connect pacing systems or diagnostic equipment without spatial constraints. No other model lengths are specified in the data.

Are there any special storage or handling requirements for the Adapter Cable beyond standard medical device protocols?

The Adapter Cable follows standard sterile or non-sterile medical device protocols for storage and handling, as dictated by procedural guidelines. Since it is disposable and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use, following manufacturer recommendations (though specific storage conditions beyond this are not detailed in the provided data).

What regulatory pathway was followed for the Adapter Cable’s approval, and which advisory committee was involved?

The Adapter Cable received FDA 510(k) clearance under the Cardiovascular (CV) advisory committee, classified as a Device Class II product. The submission was deemed substantially equivalent (SESE) to a predicate device, and the decision was finalized on May 19, 2005, with the k-number K050884. This classification ensures it meets U.S. regulatory standards for pacemaker electrode function testing.

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: Medical Accessories and Cables - Remington Medical, Electrotherapy Standardized Wires & Cords - Remington Medical, Disposable Surgical Cable (PA - 801) | Remington, Physiomed Unit Connection Cable - Remington Medical, OEM#: ADAP-2000-12 ADAP-2000-12 DISPOSABLE ADAPTER by Remington Medical Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Remington Medical, Inc.

Sources (1)

  • FDA 510(k) K050884 24 fields · synced Oct 6, 2026