External Pacemaker Wire Dressing Change
510(k) K881356
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881356 | Date19 May 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LDF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Temporary Pacemaker Electrode, designed to facilitate the secure attachment of external pacemaker wires to a patient’s chest. It provides a sterile, adhesive interface to maintain electrode positioning while minimizing skin irritation or displacement during temporary pacing procedures.
The dressing is intended for single-use in clinical settings such as emergency rooms, cardiac catheterization labs, or intensive care units. Supplied sterile in a sealed package, it adheres directly to the skin and accommodates temporary pacemaker wires (e.g., bipolar or unipolar leads) for transient cardiac rhythm support. No regulatory approvals beyond the FDA 510(k) clearance (K881356) are stated, and its use is governed by standard cardiovascular practice guidelines.
Other devices from Neal & Assoc., Inc.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is this dressing intended for and why is it designed for single-use only?
This dressing is designed for use in high-urgency clinical environments like emergency rooms, cardiac catheterization labs, and intensive care units where temporary cardiac rhythm support is required. It is intended for single-use because the sterile adhesive interface is meant to minimize skin irritation and displacement during temporary pacing procedures, ensuring patient safety and hygiene in transient, high-risk scenarios.
How is the dressing supplied, and what does the sterile packaging ensure?
The dressing is supplied sterile in a sealed package, which guarantees a clean, contamination-free surface for direct application to the patient’s skin. This sterile packaging prevents microbial contamination before use, reducing the risk of infection during temporary pacemaker wire attachment.
Can this dressing accommodate different types of temporary pacemaker wires, and if so, which ones?
Yes, the dressing is designed to accommodate both bipolar and unipolar temporary pacemaker wires. Its flexible adhesive interface ensures secure attachment while minimizing displacement, making it compatible with standard leads used for transient cardiac rhythm support.
How does the adhesive interface help reduce skin irritation during prolonged use?
The adhesive interface is formulated to distribute pressure evenly across the skin, reducing friction and shear forces that can cause irritation or displacement. This design minimizes trauma to the skin while maintaining secure electrode positioning during temporary pacing procedures.
What regulatory pathway was followed for this device, and how does it relate to its use in clinical practice?
This device followed the FDA’s 510(k) clearance pathway (K881356) under the Cardiovascular advisory committee, demonstrating substantial equivalence to a predicate device. While the clearance confirms its compliance with U.S. regulations, its use in clinical practice is governed by standard cardiovascular practice guidelines for temporary pacing procedures.