Hewlett Packard Multi Function Adult Defib Electrode, Model M3501A & M3502A
by Hewlett-Packard Co. 510(k)
Active
510(k) K991871
Overview
The Hewlett Packard Multi Function Adult Defib Electrode, Models M3501A & M3502A, is a disposable, non-sterile device designed for external defibrillation, pacing, and cardiac monitoring in adult patients. These electrodes provide the conductive interface between the patient’s skin and defibrillation devices, enabling delivery of therapeutic electrical shocks during cardiac emergencies.
Supplied as single-use, non-sterile electrodes, these devices are intended for use in clinical and pre-hospital settings. They are classified under product code MKJ as Automated External Defibrillators (Non-Wearable) and have received FDA 510(k) clearance under the Cardiovascular Advisory Committee. Storage should follow manufacturer guidelines to maintain functionality, and proper disposal adheres to medical waste regulations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991871 | Date5 Aug 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hewlett-Packard Co.
Questions
Are these electrodes suitable for use on pediatric patients, or are they strictly for adults only?
These electrodes are explicitly designed for adult patients only, as stated in the device name and description. The term *adult* is included to clarify the intended patient population, and there is no mention of pediatric use or sizing in the provided data. Always verify patient-specific guidelines before use.
How should these electrodes be stored to ensure they remain functional and safe for use?
The manufacturer recommends following storage guidelines to maintain functionality, though specific conditions (e.g., temperature, humidity) are not detailed in the provided data. Generally, disposable medical devices like these should be stored in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Check the packaging for any additional instructions.
Can these electrodes be reused after a single use, or are they strictly single-use devices?
These electrodes are single-use only, as explicitly stated in the description. They are designed for one-time application to ensure hygiene and safety, particularly in critical cardiac emergencies. Reuse is not recommended or supported by the manufacturer.
What is the regulatory pathway for this device, and which committee reviewed its clearance?
This device received FDA 510(k) clearance under the Cardiovascular Advisory Committee (CV). The clearance was granted as *substantially equivalent* to a predicate device, and the submission was filed under product code MKJ (Automated External Defibrillators, Non-Wearable). The decision was made in 1999, as noted in the regulatory data.
What types of electrical functions do these electrodes support, beyond just defibrillation?
Beyond defibrillation, these electrodes support external pacing and cardiac monitoring in adult patients. They serve as the conductive interface between the patient’s skin and defibrillation devices, enabling therapeutic electrical shocks *and* facilitating monitoring and pacing functions during cardiac emergencies.