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Neos - M Abp

by Biotronik Sales, Inc. 510(k)

Active United States

510(k) K853058

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853058 Date13 Sep 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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-M ABP is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart when spontaneous contractions are insufficient. It is classified as a Class III device under the FDA’s regulatory framework, intended for patients requiring chronic pacing support, including those with bradycardia or conduction disorders.

This device is supplied sterile and intended for single-use implantation, though the pulse generator itself may be reusable in certain configurations. It is MRI-unsafe and must be stored in accordance with manufacturer guidelines to preserve functionality. Authorized under FDA 510(k) clearance (K853058), it adheres to regulatory standards for cardiovascular implantable devices, including compliance with 21 CFR 870.3610 for pacemaker systems.

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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 types of patients is the NEOS-M ABP intended to support with pacing therapy?

    The NEOS-M ABP is designed for patients who require chronic pacing support due to bradycardia (slow heart rate) or conduction disorders, ensuring consistent cardiac rhythm regulation through electrical impulse delivery.

  • Is the NEOS-M ABP pulse generator reusable, and if so, under what conditions?

    While the device itself is supplied sterile and intended for single-use implantation, the pulse generator *may* be reusable in certain configurations—though this depends on clinical practice and manufacturer guidelines, not the device’s core specifications.

  • How should the NEOS-M ABP be stored to maintain its functionality?

    The device must be stored strictly according to Biotronik’s manufacturer guidelines to preserve its functionality, though the data does not specify exact conditions—clinicians should refer to the provided instructions for proper handling.

  • What regulatory pathway was followed for FDA clearance of the NEOS-M ABP?

    The NEOS-M ABP received FDA clearance via a Traditional 510(k) process (K853058), determined *substantially equivalent* to a predicate device, and reviewed by the Cardiovascular (CV) Advisory Committee under the DXY product code.

  • Can the NEOS-M ABP be used in patients requiring MRI procedures?

    No, the NEOS-M ABP is MRI-unsafe, meaning it should not be implanted in patients who require magnetic resonance imaging due to potential risks from electromagnetic interference.