700-MP Disposable Radiolucent Multi-Pad Electrodes
by Cardiotronics Systems, Inc.
510(k) K970719
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970719 | Date16 Apr 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- Withdrawn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 700-MP Disposable Radiolucent Multi-Pad Electrodes are single-use, adhesive electrodes designed for use with automated external defibrillators (non-wearable). These electrodes feature multiple adhesive pads that provide reliable electrical contact for defibrillation and monitoring during cardiac emergencies, while their radiolucent material ensures visibility during X-ray imaging.
Supplied as sterile, single-patient-use devices, these electrodes are intended for use in emergency medical settings, including pre-hospital and in-hospital environments. They are classified as Class III medical devices under FDA regulations (870.5310) and were granted 510(k) clearance through the Cardiovascular Advisory Committee. Each unit is packaged for immediate clinical use and must be stored according to manufacturer instructions to maintain sterility and performance.
Other devices from Cardiotronics Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these electrodes reusable or intended for single-use only, and why does that matter in an emergency setting?
These electrodes are explicitly designed for single-use only, as stated in the description. This is critical in emergency settings because single-use devices minimize the risk of cross-contamination between patients, ensuring sterility and reducing infection risks during life-saving interventions like defibrillation. Reusing them could compromise patient safety and regulatory compliance.
How do I ensure the electrodes remain effective once they arrive at the clinical site?
The electrodes must be stored according to the manufacturer’s instructions to maintain sterility and performance. Since they are supplied as sterile, single-patient-use devices, improper storage—such as exposure to moisture, extreme temperatures, or direct sunlight—could degrade adhesive properties or compromise radiolucency. Always check the packaging for expiration dates and storage guidelines before use.
Can these electrodes be used with any automated external defibrillator (non-wearable), or are there compatibility restrictions?
The electrodes are designed for use with automated external defibrillators (non-wearable) but do not specify compatibility with all models. While the device description implies broad applicability, it’s always best to verify compatibility with your specific defibrillator model. The manufacturer’s instructions should clarify any restrictions or recommended pairings to ensure proper function during emergencies.
What makes these electrodes radiolucent, and why is that feature important during cardiac emergencies?
The electrodes are made from radiolucent material, meaning they allow X-rays to pass through without blocking the view. This is essential in emergency settings where patients may require imaging (e.g., chest X-rays) to assess conditions like pneumothorax or placement of medical devices. Visibility ensures clinicians can continue monitoring or treating the patient without removing the electrodes, reducing delays in care.
How do I know if these electrodes are still suitable for use after they’ve been opened but not yet applied?
The electrodes are sterile and single-patient-use, so once the packaging is opened, they should be used immediately on the assigned patient. If not used right away, they cannot be safely reused or stored for later use due to potential contamination risks. Always follow the manufacturer’s guidelines for handling opened sterile devices to avoid compromising patient safety.