510(k) · Cleared
ClearedPediatric Energy Reducer, Models Aed-10 and Aed-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Sep 14, 2004 as substantially equivalent to K022732 (Medtronic Physio-Control Corp., 2002) after a 202-day review. Its family tree reaches back 2 generations to 2001. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 14, 2004
- Review
- 202 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003819 (2001). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK003819 Heartstream Attenuated Defibrillation Pads, Model M3870AAgilent Technologies, Inc. · 2001 · Recalled
- 1 generation backK022732 Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Recalled (Class I)
- This deviceK040479 Pediatric Energy Reducer, Models Aed-10 and Aed-20Welch Allyn, Inc. · 2004
Class I recalls in this family
- K022732 Infant/Child Reduced Energy Electrodesdirect predicate · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870A | Agilent Technologies, Inc. | 2001 | 4 |
| −1 | K022732 | Infant/Child Reduced Energy Electrodes | Medtronic Physio-Control Corp. | 2002 | Class I |
| 0 (this device) | K040479 | Pediatric Energy Reducer, Models Aed-10 and Aed-20 | Welch Allyn, Inc. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022732 | Infant/Child Reduced Energy ElectrodesSummary page 1…870.531 0, Defibrillator, Automatic, External Predicate Device: Medtronic PhysIo-Control Infant/Child Reduced Energy Electrodes (K022732) Class Ill Common Names: Defibrillator, Automatic, External (MKJ) and El… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022732Infant/Child Reduced Energy ElectrodesMedtronic Physio-Control Corp. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K022732.
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?
The Pediatric Energy Reducer product is intended to be used to treat patients in cardiopulmonary arrest. It should only be used on patients who are unconscious, without a pulse and not breathing spontaneously. It is intended for use in either in-hospital or out-of-hospital arrests. The Pediatric Energy Reducer is to be used only in conjunction with Automatic External Defibrillator (AED) and disposable electrode products marketed by Welch Allyn, or as…
Read the full statement (178 words)
The Pediatric Energy Reducer product is intended to be used to treat patients in cardiopulmonary arrest. It should only be used on patients who are unconscious, without a pulse and not breathing spontaneously. It is intended for use in either in-hospital or out-of-hospital arrests. The Pediatric Energy Reducer is to be used only in conjunction with Automatic External Defibrillator (AED) and disposable electrode products marketed by Welch Allyn, or as formerly marketed by Medical Research Laboratories (MRL). The AED 1OTM was formerly marketed as the MRL JumpStart and AED 2 0TM was formerly marketed as the MRL LifeQuest AEDefibrillator.
The Pediatric Energy Reducer product is intended to be used to treat infants and children up to approximately 8 years of age or 25 kg (55 lbs) weight; therapy should not be delayed to determine the child's exact age or weight.
It is intended to be used with normal (non-attenuating) adult electrodes on patients who are sufficiently large for the electrodes to be applied (in the anterior / posterior position), or with normal (non-attenuating) pediatric electrodes on smaller patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040479: Pediatric Energy Reducer, Models Aed-10 and Aed-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040479
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026