Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504A
by Hewlett-Packard Co. 510(k)
Active
510(k) K992977
Overview
This device is an Automated External Defibrillator (Non-Wearable) designed for pediatric use. It delivers defibrillation shocks, provides external transcutaneous pacing, and enables cardiac monitoring to support emergency cardiac interventions in pediatric patients.
The Models M3503A and M3504A are non-sterile, single-use devices intended for conductive interfacing between the defibrillator/pacemaker and pediatric patients. Supplied as disposable electrodes, they are regulated under FDA 510(k) clearance (K992977) and classified as Class III medical devices. Storage and handling follow standard non-sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992977 | Date1 Dec 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- Withdrawn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 pediatric defibrillator electrodes reusable or single-use, and how should they be handled after use?
The Hewlett-Packard M3503A and M3504A pediatric defibrillator electrodes are single-use, non-sterile devices. After use, they should be disposed of according to standard medical waste protocols for non-sterile, single-use electrodes. Since they are not sterile, they should not be reused or reprocessed.
What storage conditions are recommended for these pediatric defibrillator electrodes?
As non-sterile medical devices, the M3503A and M3504A electrodes should be stored following standard protocols for non-sterile medical devices. This typically includes keeping them in a clean, dry environment, protected from extreme temperatures, moisture, and direct sunlight. Always refer to the manufacturer’s instructions for specific storage guidelines.
What is the regulatory pathway for these pediatric defibrillator electrodes, and how were they cleared?
The M3503A and M3504A pediatric defibrillator electrodes were cleared through the FDA 510(k) process under the classification of Class III medical devices. The clearance (K992977) was granted in 1999, with a decision stating they are substantially equivalent to a predicate device. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and filed under product code MKJ.
What is the primary purpose of these electrodes in a pediatric emergency setting?
These electrodes serve as disposable conductive interfaces between the defibrillator/pacemaker and pediatric patients. They enable the delivery of defibrillation shocks and external transcutaneous pacing, while also supporting cardiac monitoring during emergency interventions. They are specifically designed for pediatric use, ensuring proper electrical conduction for life-saving procedures.