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TRIOS 02

FDA 510(k)

Class III (US FDA 510(k))

510(k) K905087

by Biotronik, GmbH & Co.

Identifiers

510(k) Number
K905087 FDA 510(k)
FDA Product Code
DXY FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3610 FDA 510(k)
Regulation Number
870.3610 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TRIOS 02 is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is intended for patients requiring temporary or permanent pacing support to manage bradycardia or other conduction disorders.

The TRIOS 02 is supplied as a reusable, implantable medical device and is classified under FDA regulation number 870.3610. It is intended for use in clinical settings by qualified healthcare professionals, adhering to sterile procedures for implantation. The device is authorised under FDA 510(k) clearance (K905087) and falls under the Cardiovascular advisory committee classification.

Frequently asked questions

What types of cardiac conditions is the TRIOS 02 designed to address, and how does it work?

The TRIOS 02 is specifically designed to manage bradycardia and other conduction disorders by regulating cardiac rhythm. It achieves this through electrical impulse delivery to the heart, providing temporary or permanent pacing support for patients who require such intervention. This device is intended for use in clinical settings by qualified healthcare professionals.

Is the TRIOS 02 a single-use or reusable device, and how should it be handled during implantation?

The TRIOS 02 is a reusable, implantable medical device. Due to its nature, it must be handled under sterile procedures during implantation to ensure patient safety and device integrity. Only qualified healthcare professionals should perform the implantation.

What regulatory pathway was followed for the TRIOS 02, and what does this mean for its use?

The TRIOS 02 received FDA clearance through a 510(k) submission (K905087) and is classified under FDA regulation number 870.3610 for Implantable Pacemaker Pulse-Generators. This clearance indicates the device was deemed substantially equivalent to a legally marketed predicate, ensuring it meets regulatory standards for safety and effectiveness. Its classification under the Cardiovascular advisory committee reflects its specialized use in cardiac rhythm management.

Are there multiple models or sizes available for the TRIOS 02, and how would I identify the correct one for a patient?

The provided data does not specify distinct models or sizes for the TRIOS 02, but it is listed under product code DXY and has multiple FEI numbers (e.g., 3002807576, 2017865), which may correspond to variations or lot-specific identifiers. To determine the correct device for a patient, consult the manufacturer’s documentation or a healthcare professional, as selection depends on clinical needs, patient anatomy, and compatibility with existing leads or systems.

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: TRIOS 02 (K905087) — FDA 510 (k) | Innolitics, K905087 FDA 510(k) - TRIOS 02 | Biotronik, GmbH & Co., 510(k) Premarket Notification - Food and Drug Administration, Trios 02 510 (k) FDA Premarket Notification K905087 BIOTRONIK, GMBH & CO., Biotronik Trios 02 - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, GmbH & Co.

Sources (1)

  • FDA 510(k) K905087 24 fields · synced Sep 18, 2026