Pediatric Energy Reducer, Models AED-10 and AED-20
510(k) K040479
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040479 | Date14 Sep 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 18 Sep 2026
The Pediatric Energy Reducer is an accessory for Automated External Defibrillators (Non-Wearable), designed to reduce the defibrillation energy delivered to pediatric patients. It adheres to the nomenclature for non-wearable defibrillator attachments, ensuring compatibility with standard AED systems while providing scaled energy levels appropriate for children.
This device is intended for single-use in emergency cardiac resuscitation settings, where it attaches directly to the defibrillator pads or paddles. Supplied as a sterile, disposable component, it requires no additional sterilization or reprocessing. The models AED-10 and AED-20 are classified under FDA regulation 870.5310 and were granted 510K clearance through the Traditional pathway, reviewed by the Cardiovascular Advisory Committee. Storage should follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Welch Allyn, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Pediatric Energy Reducer, and how does it differ from standard defibrillator pads for adults?
The Pediatric Energy Reducer is designed specifically to reduce the defibrillation energy delivered to pediatric patients during cardiac resuscitation. Unlike standard adult defibrillator pads, it attaches directly to the defibrillator pads or paddles to scale the energy output appropriately for children, ensuring safer use in emergency situations.
Are the Pediatric Energy Reducer models AED-10 and AED-20 reusable, or are they intended for single-use?
The Pediatric Energy Reducer is explicitly intended for single-use in emergency cardiac resuscitation. It is supplied as a sterile, disposable component, meaning it should not be reused or reprocessed after use.
How should the Pediatric Energy Reducer be stored to maintain its sterility and functionality?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is a sterile, single-use accessory, proper storage conditions are critical to ensure it remains effective when needed in emergency situations.
What regulatory pathway was followed for the FDA clearance of the Pediatric Energy Reducer, and which advisory committee reviewed it?
The Pediatric Energy Reducer was cleared through the FDA’s Traditional 510(k) pathway, reviewed by the Cardiovascular Advisory Committee. This pathway was used to demonstrate substantial equivalence to legally marketed devices in the same category.
What types of Automated External Defibrillators (Non-Wearable) is the Pediatric Energy Reducer compatible with?
The Pediatric Energy Reducer is designed as an accessory for standard Automated External Defibrillators (Non-Wearable) and adheres to nomenclature for non-wearable defibrillator attachments. While the exact compatibility list isn’t detailed here, its design ensures it works with most widely used AED systems that utilize defibrillator pads or paddles.