DCI Model EP-2 Clinical Stimulator
by Digital Cardiovascular Instruments, Inc. 510(k)
Active
510(k) K854196
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854196 | Date1 May 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- DRO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5550
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DCI Model EP-2 Clinical Stimulator is an external transcutaneous (non-invasive) cardiac pacemaker. It delivers electrical impulses to the heart muscle through the chest wall to regulate abnormal heart rhythms, such as bradycardia or heart block, in clinical settings. Designed for temporary cardiac support, it provides pacing functionality without surgical implantation, making it suitable for emergency or diagnostic scenarios. The device operates as a Class II medical device under FDA classification.
This device is intended for single-use or reusable applications in controlled clinical environments, as determined by the manufacturer’s specifications. It is regulated under FDA 510(k) clearance (K854196) and falls under the regulation number 870.5550, ensuring compliance with U.S. medical device standards. The stimulator is supplied as a portable unit with adjustable pacing parameters, intended for use by trained healthcare professionals in cardiac care units or emergency departments. No MRI safety information or sterility specifications are provided in the available data.
Questions
AI-generated answers, 1 Oct 2026
What is the DCI Model EP-2 Clinical Stimulator used for?
The DCI Model EP-2 Clinical Stimulator is an external transcutaneous (non-invasive) cardiac pacemaker. It delivers electrical impulses through the chest wall to regulate abnormal heart rhythms, such as bradycardia or heart block, in clinical settings. This device provides temporary cardiac support without requiring surgical implantation, making it ideal for emergency or diagnostic scenarios where immediate pacing is needed.
Is the DCI Model EP-2 Clinical Stimulator single-use or reusable?
The DCI Model EP-2 Clinical Stimulator is designed for either single-use or reusable applications, depending on the manufacturer’s specifications for controlled clinical environments. Reusability would require adherence to strict cleaning, disinfection, and maintenance protocols to ensure safety and functionality for repeated use.
What are the key features of the DCI Model EP-2 Clinical Stimulator?
The DCI Model EP-2 is a portable unit with adjustable pacing parameters, allowing healthcare professionals to customize stimulation for patient needs. It operates as a Class II medical device under FDA classification and is intended for use by trained clinicians in cardiac care units or emergency departments. The device is designed to provide temporary pacing support without the need for invasive procedures.
Does the DCI Model EP-2 Clinical Stimulator come with MRI safety information?
The available data for the DCI Model EP-2 Clinical Stimulator does not include any specific MRI safety information. If MRI compatibility is required, additional research or manufacturer documentation should be consulted to ensure safe use in magnetic resonance environments.
What regulatory pathway does the DCI Model EP-2 Clinical Stimulator follow?
The DCI Model EP-2 Clinical Stimulator is regulated under the FDA 510(k) clearance pathway, with the clearance number K854196. It falls under the regulation number 870.5550, ensuring compliance with U.S. medical device standards. The device was classified as substantially equivalent to a predicate device and reviewed by the FDA’s Cardiovascular Advisory Committee.