Identifiers
- 510(k) Number
- K953204 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pediatric Quik-Combo is an Automated External Defibrillator (Non-Wearable) designed for pediatric use. It delivers electrical shocks to restore normal heart rhythm in children experiencing sudden cardiac arrest, incorporating defibrillation capabilities tailored to pediatric patients.
This device is supplied as a reusable medical instrument and is intended for use in emergency cardiovascular settings. It requires compatibility with specific pediatric electrode systems, such as the EDGE System RTS, and is not approved for use with Automated External Defibrillators (AEDs). The device holds an FDA 510(k) clearance (K953204) under the classification of Class III, reflecting its high-risk, life-sustaining nature. Storage and handling must adhere to manufacturer guidelines to ensure proper functionality.
Frequently asked questions
What is the Pediatric Quik-Combo used for in emergency settings?
The Pediatric Quik-Combo is an Automated External Defibrillator (Non-Wearable) specifically designed to deliver electrical shocks to restore a normal heart rhythm in children experiencing sudden cardiac arrest. It is tailored for pediatric patients and is intended for use in emergency cardiovascular situations where immediate intervention is critical.
Is the Pediatric Quik-Combo a single-use or reusable device?
The Pediatric Quik-Combo is a reusable medical instrument. It is built to be used repeatedly in emergency settings, provided it is properly maintained and stored according to the manufacturer’s guidelines to ensure functionality and safety.
What pediatric electrode systems are compatible with the Pediatric Quik-Combo?
The device requires compatibility with specific pediatric electrode systems, such as the EDGE System RTS. It is explicitly not approved for use with standard Automated External Defibrillators (AEDs), emphasizing its specialized design for pediatric patients.
How should the Pediatric Quik-Combo be stored to maintain its functionality?
Storage and handling of the Pediatric Quik-Combo must follow the manufacturer’s guidelines to ensure proper functionality. Since it is reusable, adherence to these instructions is critical to maintaining its performance and reliability in emergency situations.
What regulatory pathway was followed for FDA clearance of the Pediatric Quik-Combo?
The Pediatric Quik-Combo holds an FDA 510(k) clearance (K953204) under the classification of Class III, which reflects its high-risk, life-sustaining nature. The clearance was granted through a traditional review process by the FDA’s Cardiovascular (CV) advisory committee, confirming its substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Physio-Control Pediatric Quik-Combo - allmed.wiki, PEDIATRIC QUIK-COMBO (K953204) — FDA 510(k) | Innolitics, Physio-Control Electrodes Pediatric EDGE System RTS with QUIK-COMBO ..., Pediatric Quik Combo RTS Defibrillation Pads by Physio Control
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953204 | Class III | Active |
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Manufacturer
- Manufacturer
- Physio-Control Corp.
Sources (1)
- FDA 510(k) K953204 24 fields · synced Sep 18, 2026