← Product Code [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF) · K970289 # COMPRESSOR/NEBULIZER #3650 (K970289) _Devilbiss Health Care, Inc. · CAF · Apr 15, 1997 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K970289 ## Device Facts - **Applicant:** Devilbiss Health Care, Inc. - **Product Code:** [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF.md) - **Decision Date:** Apr 15, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5630 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. ## Device Story System comprises compressor and jet (pneumatic) nebulizer; converts liquid medication into aerosol for inhalation. Used in clinical or home settings under physician order. Compressor generates pneumatic pressure to drive nebulizer; produces aerosol with majority of mass in particles < 5 microns diameter. Healthcare provider prescribes device; patient self-administers aerosolized medication. Benefits include targeted delivery of medication to respiratory tract for disease management. ## Clinical Evidence Bench testing only. Performance evaluation confirms aerosol output with majority of mass in particles < 5 microns diameter, meeting BSI standard requirements. Comparison of safety and effectiveness data against predicate devices provided. ## Technological Characteristics Pneumatic compressor/nebulizer system. Materials: metal and plastic. Energy source: electrical. Output: aerosolized medication. Particle size: >50% mass < 5 microns. Compliance: UL1431 (electrical/mechanical safety), BSI standard (aerosol performance). ## Regulatory Identification A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device. ## Predicate Devices - DeVilbiss Model 5650 ([K923888](/device/K923888.md)) - Healthdyne, Inc. 323 ([K922623](/device/K922623.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970289 APR 15 1997 # 3.0 Summary of Safety and Effectiveness The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. In terms of function, safety and effectiveness this device is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431, Attachment D). Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3650 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E). This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 6.0 & 7.0). The Table of Comparison and the Performance Evaluations (Sections 6.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3650 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices. Legally Marketed Predicate Devices DeVilbiss Model 5650 Healthdyne, Inc. 323 510(k) Registration # K 923888 K 922623 3650pt3.doc 01/23/97 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K970289](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K970289) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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