Dialog Models 748, 748K, and 748T Pulse Generators
by Pacesetter Systems 510(k)
Active
510(k) K862226
Overview
The Dialog Models 748, 748K, and 748T are implantable pacemaker pulse generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are classified as Class III medical devices under FDA regulations, intended for use in patients requiring cardiac pacing to manage bradycardia or other conduction disorders.
These pulse generators are intended for surgical implantation and are supplied sterile for single-use. They are regulated under FDA 510(k) clearance (K862226) and fall under the classification of implantable pacemaker pulse-generators, adhering to the regulatory requirements outlined in 21 CFR 870.3610. Each model (748, 748K, and 748T) is distinct in its specifications, as detailed in the original submission, and must be used in accordance with established clinical guidelines for pacemaker therapy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862226 | Date3 Feb 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Models / Variants
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
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.