Ambu Pediatric Multi-Function Defibrillation Electrode
by Ambu, Inc. 510(k)
Active
510(k) K032421
Overview
The Ambu Pediatric Multi-Function Defibrillation Electrode is a disposable, single-use device classified as an Automated External Defibrillator (Non-Wearable). It is designed to capture electrocardiogram (ECG) signals for monitoring and deliver electrical energy for defibrillation, pacing, or synchronized cardioversion in pediatric patients. The electrode interfaces with external defibrillators and transcutaneous pacemakers to provide therapeutic interventions and real-time cardiac assessment.
Supplied as a sterile, single-use device, the Ambu Pediatric Multi-Function Defibrillation Electrode is intended for use in clinical settings by healthcare professionals. It is compatible with both mono- and biphasic defibrillators and features specific connector/cable configurations for proper integration. The device holds an FDA 510(k) clearance under the Cardiovascular advisory committee, with a classification of Class III and regulation number 870.5310. Storage and handling follow standard sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032421 | Date27 Feb 2004 | 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- Withdrawn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 Ambu, Inc.
Questions
What is the primary purpose of the Ambu Pediatric Multi-Function Defibrillation Electrode, and who should use it?
The Ambu Pediatric Multi-Function Defibrillation Electrode is designed to capture ECG signals for real-time cardiac monitoring and deliver electrical energy for defibrillation, pacing, or synchronized cardioversion in pediatric patients. It is intended exclusively for use by healthcare professionals in clinical settings, as it interfaces with external defibrillators and transcutaneous pacemakers to provide therapeutic interventions.
Is the Ambu Pediatric Multi-Function Defibrillation Electrode reusable or single-use, and how should it be stored?
The device is explicitly labeled as a sterile, single-use product, meaning it is intended for one-time use only. Storage and handling must follow standard sterile medical device protocols to maintain its integrity until use.
What types of defibrillators is this electrode compatible with, and how does it connect?
The Ambu Pediatric Multi-Function Defibrillation Electrode is designed to work with both monophasic and biphasic defibrillators. It features specific connector/cable configurations to ensure proper integration with external defibrillators and transcutaneous pacemakers, allowing for accurate ECG monitoring and therapeutic interventions.
How was the regulatory clearance for this device obtained, and what classification does it fall under?
The device holds an FDA 510(k) clearance under the Cardiovascular advisory committee, classified as Class III with regulation number 870.5310. The clearance was granted through a traditional review process, with the device deemed substantially equivalent to a predicate.