# K040479: Pediatric Energy Reducer, Models Aed-10 and Aed-20

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Sep 14, 2004 after 202 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
Longest line of descent: 2 generations back to K003819 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022732: Infant/Child Reduced Energy Electrodes, Medtronic Physio-Control Corp. (2002) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K040479
Methodology: https://510kreport.com/methodology