Medi-Trace 1510M Combination Defibrillation, Monitoring, and Pacing Electrode
510(k) K972970
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972970 | Date27 Aug 1997 | 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- Withdrawn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
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Medi-Trace 1510M Combination Defibrillation, Monitoring, and Pacing Electrode is a reusable medical device designed for automated external defibrillation, cardiac monitoring, and temporary cardiac pacing. It integrates multiple functionalities into a single electrode system, enabling simultaneous defibrillation shocks, real-time ECG monitoring, and pacing stimulation to support emergency cardiovascular interventions.
This device is intended for use in clinical settings such as hospitals, emergency rooms, and pre-hospital emergency care. Supplied as a reusable component, it requires proper cleaning and sterilization between uses to maintain safety and efficacy. The Medi-Trace 1510M is classified as a Class III device under FDA regulations (870.5310) and holds a Traditional 510(k) clearance (K972970) for cardiovascular applications, adhering to strict regulatory standards for defibrillation and pacing electrodes.