đź“‹ FDA Reference
Self-Sealing Water Trap Adult Paediatric Circuits
Dhd Medical Products Div. Diemolding
Summary: The self-sealing water trap adult paediatric circuits by Dhd Medical Products are used in respiratory care to manage moisture in breathing circuits. They are primarily used by respiratory therapists and clinicians in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860883 ↗
Decision Date ?
March 19, 1986
Product Code ?
BYH
Device Class ?
Class 1
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on March 19, 1986. It is manufactured by Dhd Medical Products Div. Diemolding and classified as a Class 1 device under product code BYH.
What It Is
The self-sealing water trap is a component used in respiratory circuits to collect and manage condensation that forms during mechanical ventilation. It helps maintain circuit integrity by preventing water from entering the patient's airway. The self-sealing feature allows for easy removal and disposal without interrupting ventilation.
FDA-Cleared Indications
- Managing condensation and accumulated moisture in breathing circuits used for mechanical ventilation.
- Use in adult and pediatric respiratory-care circuits.
- Collection and removal of water from compatible ventilator breathing circuits.
Clinical Applications
- Moisture management during invasive mechanical ventilation in adult patients.
- Moisture management during invasive mechanical ventilation in pediatric patients.
- Collection of condensation in intensive care and other hospital respiratory-care settings.
- Removal and replacement of accumulated water from compatible breathing circuits.
Practical Considerations
- Adult and pediatric circuit configurations or sizes should be matched to the ventilator circuit and patient population.
- Confirm connector compatibility with the breathing circuit and ventilator before use.
- The trap should be handled according to institutional infection-control procedures and replaced or emptied as directed by the device labeling and clinical protocol.
- Avoid allowing collected fluid to flow toward the patient airway; inspect the circuit and trap during ventilation.
- The available record does not establish MRI safety. MRI compatibility should be confirmed from the current manufacturer labeling before use in an MRI environment.
Frequently Asked Questions
What is the self-sealing water trap used for?
It is used to manage moisture in breathing circuits during mechanical ventilation, preventing water from entering the patient's airway.
What specialties typically use this device?
Respiratory therapists and critical care clinicians in hospital settings frequently use this device.
What are the FDA-cleared indications?
The device is indicated for managing moisture in breathing circuits for both adult and pediatric patients requiring mechanical ventilation.
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.