đź“‹ FDA Reference
Paediatric Face Mask 1-3 W Wo Ring
Warne Surgical Products
Summary: The paediatric face mask 1-3 w wo ring is a medical device used primarily in pediatric anesthesia to deliver gases to young patients. It is typically used by anesthesiologists and other healthcare providers in surgical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K834454 ↗
Decision Date ?
January 18, 1984
Product Code ?
BSJ
Device Class ?
Class 1
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on January 18, 1984, by Warne Surgical Products. It is classified as a Class 1 device under product code BSJ.
What It Is
The paediatric face mask 1-3 w wo ring is designed to fit the facial contours of young children, ensuring effective delivery of anesthetic gases. It may come with or without a ring to attach to anesthesia circuits. The mask is typically made of soft, pliable materials to provide comfort and a secure fit during procedures.
FDA-Cleared Indications
- Delivery of anesthetic gases to pediatric patients through a face mask.
- Use with compatible anesthesia circuits during surgical or other procedures requiring inhalational anesthesia.
- Noninvasive delivery of gases when a properly fitted pediatric face mask is clinically appropriate.
Clinical Applications
- Administering inhalational anesthetic gases to children approximately 1 to 3 years old.
- Providing a patient interface between a young child and an anesthesia breathing circuit.
- Supporting mask ventilation during induction of anesthesia when clinically indicated.
- Use in hospitals, operating rooms, and ambulatory surgical centers with compatible anesthesia equipment.
Practical Considerations
- Select the size based on the child's facial dimensions and the manufacturer's sizing guidance; age alone may not ensure a proper fit.
- The mask may be supplied with or without a ring for connection to an anesthesia circuit. Confirm connector compatibility before use.
- A good seal helps reduce gas leakage, but the mask should not be pressed excessively against the face.
- Use only as directed by trained anesthesia personnel, with continuous monitoring and equipment for airway support and rescue ventilation available.
- MRI compatibility is not established from the available FDA record. Confirm the materials and configuration with the manufacturer before use in an MRI environment.
Related Literature
The linked study compared weight-based and external ear-size based techniques for selecting laryngeal mask airways in pediatric patients. While specific findings are not detailed, such studies typically aim to optimize airway management in children. Limitations include the lack of an abstract and publication year, which restricts detailed analysis.
Frequently Asked Questions
What is the paediatric face mask 1-3 w wo ring used for?
It is used to deliver anesthetic gases to pediatric patients during surgical procedures.
What specialties typically use this device?
Anesthesiologists and pediatricians commonly use this device in surgical and hospital settings.
What are the FDA-cleared indications?
The device is indicated for delivering anesthetic gases to pediatric patients, particularly those aged 1 to 3 years, during medical procedures.
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.