Generators: UDL-201B, BDL-201B, MDL-201B
by Pacesetter Systems 510(k)
Active
510(k) K781424
Overview
The UDL-201B, BDL-201B, and MDL-201B are implantable pacemaker pulse-generators designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders. These devices deliver electrical impulses to stimulate the heart muscle, ensuring proper pacing and maintaining consistent heart function when the natural pacemaker is insufficient or malfunctioning.
These generators are intended for surgical implantation by qualified medical professionals and are classified as Class III devices under FDA regulations. They are supplied sterile and intended for single-use implantation, with no indication of MRI compatibility. Each model is identified by its unique reference code and is authorized under FDA 510(k) clearance (K781424) as substantially equivalent to predicate devices. Storage and handling must comply with sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781424 | Date27 Sep 1978 | 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- Withdrawn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
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What are the primary clinical uses for the UDL-201B, BDL-201B, and MDL-201B pacemaker pulse-generators?
These devices are designed to regulate cardiac rhythm in patients with bradycardia (slow heart rate) or conduction disorders, where the heart’s natural pacemaker fails to maintain proper function. They deliver electrical impulses to stimulate the heart muscle, ensuring consistent pacing and maintaining healthy heart function during implantation.
Are these pacemaker pulse-generators intended for reuse or single-use, and how should they be handled?
The UDL-201B, BDL-201B, and MDL-201B are explicitly intended for single-use implantation only. Since they are supplied sterile, proper sterile medical device protocols must be followed during storage, handling, and surgical implantation to prevent contamination or compromise of sterility.
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 under clearance number K781424, with a decision of substantially equivalent to predicate devices. This means the manufacturer demonstrated that the UDL-201B, BDL-201B, and MDL-201B meet the same performance standards as previously approved pacemaker generators, ensuring safety and effectiveness for treating bradycardia or conduction disorders.
Do these devices come in different models, and if so, how are they distinguished?
Yes, the three models—UDL-201B, BDL-201B, and MDL-201B—are differentiated by their unique reference codes but share the same core function of regulating cardiac rhythm. While the data does not specify technical differences between them, their classification under the same FDA 510(k) clearance (K781424) suggests they are intended for similar clinical applications, likely varying in features like pacing modes or battery life.
Are there any special storage or handling instructions for these pacemaker pulse-generators?
Since these devices are sterile upon supply, they must be stored and handled according to strict sterile medical device protocols to maintain integrity. This includes protecting them from physical damage, contamination, and exposure to conditions that could compromise their functionality before implantation by qualified medical professionals.