510(k) · Cleared
ClearedAmbu Pediatric Multi-Function Defibrillation Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ambu, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Feb 27, 2004 after a 206-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 27, 2004
- Review
- 206 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
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…
Read the full statement (124 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032421: Ambu Pediatric Multi-Function Defibrillation Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032421
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026