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NEOS 02

by Biotronik Cardiac Pacemakers

510(k) K894240

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK894240 Date26 Oct 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NEOS 02 is an implantable pacemaker pulse-generator, classified as a Class III medical device. It is designed to regulate heart rhythm by delivering electrical impulses to treat bradycardia, a condition where the heart beats too slowly to adequately circulate oxygenated blood.

This device is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K894240) and falls under the product code DXY, adhering to the regulatory requirements for high-risk, life-sustaining cardiovascular devices. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

Other devices from Biotronik Cardiac Pacemakers

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NEOS 02 pacemaker designed to treat, and how does it work?

    The NEOS 02 is designed to treat bradycardia, a condition where the heart beats too slowly, preventing adequate circulation of oxygenated blood. It works by delivering regulated electrical impulses to the heart muscle, helping to maintain a normal heart rhythm after surgical implantation.

  • Is the NEOS 02 pacemaker intended for single-use or reusable applications?

    The NEOS 02 is supplied sterile and intended for single-use only. This ensures patient safety and maintains device integrity, as reuse could compromise sterility and functionality.

  • How should the NEOS 02 be stored to preserve its sterility and performance?

    The NEOS 02 must be stored and handled according to the manufacturer’s guidelines to maintain sterility and functionality. These instructions are critical for ensuring the device remains effective for its intended use.

  • What regulatory pathway was followed for the NEOS 02, and what does that mean for its use?

    The NEOS 02 was cleared through the FDA’s 510(k) process (K894240) under product code DXY, which is reserved for high-risk, life-sustaining cardiovascular devices like implantable pacemakers. This clearance indicates the device meets FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator.

  • Are there different models or sizes available for the NEOS 02?

    The provided data does not specify multiple models or sizes for the NEOS 02. It is described as a single device type, so availability would depend on the manufacturer’s current catalog. For precise sizing or model variations, refer to the manufacturer’s documentation.