← Back to catalogue

Retrox Rx 53-Bp, Retrox Rx 60-Bp, Retrox Rx 45-Jbp, Retrox Rx 53-Jbp (Numbers 1…

FDA 510(k)

Class III (US FDA 510(k))

510(k) K981083

by Biotronik, Inc.

Identifiers

510(k) Number
K981083 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
Numbers 124 396 FDA 510(k)
124 397 FDA 510(k)
124 395 FDA 510(k)
124 000 FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

The Retrox RX series are permanent pacemaker electrodes, designed for implantation in the cardiovascular system to regulate heart rhythm. These devices are classified as Class III medical devices under FDA regulations, intended for use in patients requiring cardiac pacing support.

These electrodes are supplied sterile and intended for single-use, though they may be reusable under specific clinical conditions. They are approved for use in MRI environments under certain conditions and are subject to traditional 510(k) clearance via the FDA’s Cardiovascular (CV) advisory committee. Each model number corresponds to a specific lead configuration, with sizes and specifications detailed in the manufacturer’s documentation.

Frequently asked questions

Are these pacemaker electrodes designed for single-use only, or can they be reused under certain conditions?

The Retrox RX series electrodes are supplied sterile and intended for single-use as standard practice. However, the manufacturer notes they *may* be reusable under specific clinical conditions, which would require adherence to strict reprocessing protocols to ensure safety and efficacy.

What types of MRI environments are these devices compatible with, and are there any restrictions?

The Retrox RX series electrodes are approved for use in MRI environments under certain conditions, though the exact parameters (e.g., MRI strength, sequence type, or safety distances) are detailed in the manufacturer’s documentation. Always verify compatibility with your MRI facility’s protocols before use.

How do I determine which model number corresponds to the specific lead configuration I need for my patient?

Each model number (e.g., 124 396, 124 397) corresponds to a distinct lead configuration for the Retrox RX series. The manufacturer’s documentation specifies the size, design, and intended use for each model, so consult those materials to match the correct model to your patient’s clinical needs.

What regulatory pathway was followed for FDA clearance of these devices, and which advisory committee was involved?

The Retrox RX series underwent traditional 510(k) clearance via the FDA’s Cardiovascular (CV) advisory committee. The clearance was granted under the substantial equivalence determination, meaning the device was shown to be as safe and effective as a legally marketed predicate device in the same category.

How should these electrodes be stored to maintain their sterility and functionality before use?

Since these electrodes are supplied sterile, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s instructions specify any additional storage conditions to preserve sterility and performance until implantation.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K981083 24 fields · synced Sep 18, 2026