đź“‹ FDA Reference
Laerdal Paediatric Pocket Mask Model 820050
Laerdal Medical A/S
Summary: The Laerdal Paediatric Pocket Mask is a resuscitation device used to provide ventilation to infants and children. It is typically used by healthcare professionals in emergency settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K023805 ↗
Decision Date ?
February 11, 2003
Product Code ?
CBP
Device Class ?
Class 2
Evidence ?
0 studies
The Laerdal Paediatric Pocket Mask was cleared through the FDA 510(k) pathway on February 11, 2003. Manufactured by Laerdal Medical A/S, it is classified as a Class 2 medical device.
What It Is
The Laerdal Paediatric Pocket Mask is a compact, portable mask designed to provide effective ventilation to pediatric patients during resuscitation. It features a one-way valve and a transparent dome to allow for proper seal and visibility. The mask is designed to be used in emergency situations where manual ventilation is required.
FDA-Cleared Indications
- Providing manual ventilation to infants and children who require assistance with breathing during resuscitation.
- Use in emergency situations involving respiratory arrest or respiratory failure.
Clinical Applications
- Mouth-to-mask rescue breathing for an infant or child who is not breathing normally.
- Manual ventilation during pediatric cardiopulmonary resuscitation.
- Emergency ventilation by trained healthcare professionals, emergency medical technicians, or first responders.
- Temporary ventilation support while advanced airway equipment or definitive treatment is prepared.
Practical Considerations
- The mask must be sized and positioned to create an appropriate seal over the infant or child's nose and mouth without covering the eyes or compressing the neck.
- The one-way valve is intended to reduce contact between the patient and rescuer; inspect the valve, mask, and packaging before use and follow the manufacturer's instructions for cleaning or disposal.
- The device may be used with manual ventilation equipment and, when clinically indicated, supplemental oxygen according to the applicable equipment instructions.
- This is an emergency ventilation device and does not replace airway assessment, oxygenation, advanced airway management, or treatment of the underlying cause.
- The record does not establish that the mask is MRI safe or MRI conditional. Keep it outside the MRI environment unless the manufacturer provides specific compatibility information.
Frequently Asked Questions
What is the Laerdal Paediatric Pocket Mask used for?
It is used to provide ventilation to infants and children during resuscitation in emergency situations.
What specialties typically use this device?
This device is typically used by emergency medical technicians, pediatricians, and other healthcare providers in acute care settings.
What are the FDA-cleared indications?
The device is indicated for providing ventilation support to pediatric patients in emergency situations.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.