đź“‹ FDA Reference
Type 9290 Interface Respirator
S & W Medico Teknik
Summary: The Type 9290 Interface Respirator is a medical device used for respiratory support, primarily in surgical and critical care settings. It is used by healthcare professionals to assist patients with breathing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K896735 ↗
Decision Date ?
February 28, 1990
Product Code ?
CBK
Device Class ?
Class 2
Evidence ?
0 studies
The Type 9290 Interface Respirator was cleared through the FDA 510(k) pathway on February 28, 1990. Manufactured by S & W Medico Teknik, it is classified as a Class 2 device under product code CBK.
What It Is
The Type 9290 Interface Respirator is a medical device designed to provide respiratory support to patients who are unable to breathe adequately on their own. It functions by delivering controlled airflow to maintain adequate oxygenation and ventilation. This device is crucial in settings where patients require mechanical assistance to breathe, such as during surgery or in intensive care units.
FDA-Cleared Indications
- Mechanical ventilation for patients who cannot maintain adequate spontaneous breathing.
- Respiratory support during surgical procedures when anesthesia or the procedure impairs breathing.
- Assistance with ventilation and oxygenation in patients with inadequate respiratory function.
Clinical Applications
- Providing assisted ventilation during surgery.
- Supporting ventilation in intensive care settings.
- Providing mechanical respiratory support for patients with respiratory failure or inadequate spontaneous breathing.
- Maintaining ventilation and oxygenation under the direction of anesthesia, critical care, or respiratory therapy staff.
Practical Considerations
- Use should be limited to trained healthcare professionals who can select appropriate settings, establish a suitable patient interface, and monitor ventilation and oxygenation.
- The available FDA record and supplied text do not specify exact size options, operating parameters, or compatible ventilation systems; users should consult the device labeling and institutional equipment documentation.
- The record does not establish MRI safety. Do not bring the device into an MRI environment unless the manufacturer has provided appropriate MR safety information.
- Potential contraindications and precautions depend on the patient interface, ventilation mode, airway status, and clinical setting; follow the manufacturer’s instructions and applicable hospital protocols.
- The device requires monitoring for inadequate ventilation, oxygenation problems, air leaks, pressure-related injury, and equipment malfunction.
Frequently Asked Questions
What is the Type 9290 Interface Respirator used for?
It is used to provide mechanical respiratory support to patients who cannot breathe adequately on their own.
What specialties typically use this device?
Anesthesiologists, critical care specialists, and respiratory therapists commonly use this device in surgical and intensive care settings.
What are the FDA-cleared indications?
It is indicated for patients requiring mechanical ventilation due to respiratory failure or during surgical 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.