700-SP Series Disposable Stimulation Electrodes
by Cardiotronics Systems, Inc.
510(k) K971148
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971148 | Date15 May 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- Withdrawn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-SP Series Disposable Stimulation Electrodes are designed as single-use, adhesive electrodes for delivering electrical stimulation in automated external defibrillators (non-wearable). These electrodes facilitate cardiac defibrillation by providing a conductive pathway for the defibrillation shock to restore normal heart rhythm during cardiac arrest.
These electrodes are supplied as sterile, disposable devices intended for one-time use in emergency cardiovascular settings. They are classified as Class III medical devices under FDA regulations (870.5310) and have received FDA 510(k) clearance (K971148) as substantially equivalent to a predicate device. Each electrode is packaged individually for immediate clinical use, ensuring sterility and compatibility with automated external defibrillator systems.
Other devices from Cardiotronics Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are the 700-SP Series Disposable Stimulation Electrodes reusable or intended for single-use only, and why does this matter in an emergency setting?
The 700-SP Series electrodes are explicitly designed for single-use only, as stated in the description. This matters in emergency settings because single-use electrodes ensure sterility and reduce the risk of cross-contamination between patients, which is critical during cardiac arrest when time and hygiene are both paramount. Reusing them could compromise patient safety by introducing infection risks or degrading performance due to wear.
How are these electrodes packaged, and what does this mean for immediate clinical use?
Each electrode is packaged individually for immediate clinical use, ensuring sterility and compatibility with automated external defibrillators (AEDs). This packaging eliminates the need for additional preparation or sterilization steps, allowing clinicians to quickly apply the electrodes during a cardiac arrest without delay. The sterile, ready-to-use design is particularly valuable in emergency scenarios where speed and reliability are essential.
What types of automated external defibrillators (AEDs) are these electrodes compatible with, and how should I verify compatibility?
The 700-SP Series electrodes are designed for compatibility with non-wearable automated external defibrillators (AEDs). While the manufacturer (Cardiotronics Systems, Inc.) is implied to have tested these electrodes for use with their systems, compatibility with other AED brands should be verified by checking the device’s specifications or consulting the manufacturer’s documentation. Always ensure the electrode’s connectors match the AED’s pads or terminals to avoid malfunctions during critical moments.
How should these electrodes be stored, and what precautions should be taken to maintain their integrity?
The electrodes should be stored in their original, unopened packaging to preserve sterility and functionality. Exposure to moisture, extreme temperatures, or physical damage could compromise the adhesive properties or conductive pathways. Store them in a cool, dry place away from direct sunlight, and avoid storing them near strong chemicals or magnetic fields, which could degrade performance. Always check the packaging for integrity before use.