Skip to content

Ventralith I

by Bio Pace Technology, Inc.

510(k) K883750

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 NumberK883750 Date13 Jan 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  • Withdrawn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 Ventralith I is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart when natural conduction is insufficient. It is classified as a Class III device under FDA regulations, requiring pre-market approval due to its role in managing life-threatening cardiac conditions.

This device is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K883750) and falls under the product code DXY, with a primary indication for use in cardiac pacemaker applications. Storage and handling must comply with sterile medical device protocols to ensure proper functionality and patient safety.

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 Ventralith I used for in clinical practice and how does it work?

    The Ventralith I is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering timed electrical impulses to the heart when the body’s natural conduction system fails. It is specifically intended for patients with insufficient cardiac conduction, helping to maintain a proper heartbeat and prevent life-threatening arrhythmias. The device is surgically implanted and continuously monitors heart activity, providing electrical stimulation as needed.

  • Is the Ventralith I intended for single-use or can it be reused after sterilization?

    The Ventralith I is supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, functionality, or patient safety. Proper sterile handling and disposal protocols must be followed to ensure compliance with medical device regulations.

  • How should the Ventralith I be stored to maintain its integrity before implantation?

    The Ventralith I must be stored according to sterile medical device protocols to preserve its functionality and sterility. Since it is supplied sterile for single-use, it should remain in its original packaging until immediately before implantation. Exposure to moisture, extreme temperatures, or contamination must be avoided, as these factors could degrade performance or compromise sterility.

  • What regulatory pathway does the Ventralith I follow, and how does that affect its use?

    The Ventralith I was cleared through the FDA’s 510(k) process (K883750) under the product code DXY, with a classification as a Class III device for life-supporting cardiac applications. This clearance confirms its substantial equivalence to a predicate device and ensures it meets FDA safety and effectiveness standards for pacemaker pulse-generators. Clinicians and buyers should confirm compliance with the manufacturer’s instructions and sterile handling guidelines to align with regulatory requirements.