Dialog Models 748, 748K, and 748T Pulse Generators - 748

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

510(k) Number

K862226 ↗

FDA Product Code

DXY

Models / Variants

748

748K

748T Pulse Generators

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascutek Vascular Prothesis VP1200K/50K

  Class II

  FDA 510(k) K830016 Active Cleared 21 Dec 1983

• Vivalith 5 - MDL-201A & TDL-201A

  Class III

  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K891905 Active Cleared 5 Jun 1989

• Pacemaker Connector Plug

  Class II

  FDA 510(k) K821548 Active Cleared 2 Jun 1982

• Personal Medication Infuser

  Class II

  FDA 510(k) K830570 Active Cleared 24 Mar 1983

• Pacemaker Unipolar Adapter

  Class II

  FDA 510(k) K821547 Active Cleared 2 Jun 1982

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• Are these pulse generators reusable or intended for single-use after implantation? Why does this matter?

  The Dialog Models 748, 748K, and 748T pulse generators are supplied sterile and intended for single-use only. This is critical because they are implanted surgically, and reusing an implanted device poses significant risks to patient safety, including infection and device failure. Single-use ensures compliance with sterile surgical protocols and minimizes complications.

• What storage conditions are recommended for these devices before implantation, and why?

  While the exact storage instructions are not detailed in the provided data, implantable pulse generators like these typically require controlled room temperature (15–30°C) and protection from moisture or extreme humidity to maintain sterility and functionality. Since they are sterile upon packaging, improper storage could compromise their integrity before use, risking contamination or device degradation during surgery.

• How do the models 748, 748K, and 748T differ in their intended clinical use or specifications?

  The data specifies that each model (748, 748K, and 748T) has distinct specifications, though the exact differences (e.g., pacing modes, battery life, or programming features) are not detailed here. Clinically, these variations likely cater to different patient needs—such as single-chamber vs. dual-chamber pacing or specific bradycardia management requirements. Always refer to the manufacturer’s instructions for model-specific guidance.

• What regulatory pathway was followed for FDA clearance of these devices, and what does that mean for clinicians?

  These pulse generators were cleared via the FDA 510(k) pathway (K862226), classified as substantially equivalent to a predicate device under 21 CFR 870.3610. This means the manufacturer demonstrated that the Dialog models meet the same safety and effectiveness standards as previously approved pacemakers, ensuring they comply with FDA requirements for implantable cardiac devices. Clinicians can rely on this clearance as evidence of regulatory scrutiny.

• Are these devices intended for use in specific patient populations, or are they broadly applicable for bradycardia?

  The devices are intended for patients requiring cardiac pacing to manage bradycardia or conduction disorders, as outlined in their FDA classification. While the exact patient populations aren’t specified beyond this, they are designed for standard pacemaker therapy under clinical guidelines. Special considerations (e.g., pediatric vs. adult use) would depend on the model’s specifications, which should be verified with the manufacturer’s documentation.