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U.S. Department of Health and Human Services

Product Classification
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Device ventilator-compatible nebulizer
Regulation Description Nebulizer.
Definition The device is intended to deliver nebulized medications through a ventilator breathing circuit.
Physical State The device is inserted into the ventilator breathing circuit to deliver nebulized medications. It may also be connected to the ventilator to allow for detection of nebulization parameters or synchronization of patient breath.
Technical Method The nebulizer may employ jet nebulization, pneumatic nebulization, vibrating mesh nebulization, or another similar technical method to achieve its intended use.
Target Area Used in the respiratory system with nebulized medications.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeSFP
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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