# K032421: Ambu Pediatric Multi-Function Defibrillation Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ambu, Inc.
- Decided: Feb 27, 2004 after 206 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Ambu Paediatric Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardicversion. The Paediatdc Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class IItype of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA inpulse duration not to exceed 200 m sec. The electrode can be used with mono- and biphasic defibrillators. The electrode is intended for use on pediatric patients whose weight is less than !0kg (221bs). Disposable electrode, for single use, only. The electrode is intended for use on defibrillators who's output is maximum 100 Joule. Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.

Source page: https://510kreport.com/device/K032421
Methodology: https://510kreport.com/methodology