CPI Model 6240 50 PSI Nebulizer Compressor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964994 ↗

FDA Product Code

CAF

Device Class

Class II

Regulation

21 CFR Part 868.5630

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Cpi Model 6260, 6260A or 6261 Oil-Less Aspirator

  Class II

  FDA 510(k) K963558 Active Cleared 4 Dec 1996

• 6203

  Class II

  FDA 510(k) K022865 Active Cleared 13 Feb 2003

• OCD2001

  Class II

  FDA 510(k) K992935 Active Cleared 20 Jun 2000

• Contempro-Mist

  Class II

  FDA 510(k) K000543 Active Cleared 16 Jun 2000

• What clinical environments is the CPI Model 6240 50 PSI Nebulizer Compressor intended for use in, and why is this important?

  The CPI Model 6240 is specifically designed for use in anesthesia and respiratory care settings, such as operating rooms, recovery areas, or respiratory therapy departments. This is important because it ensures the device operates in controlled environments where precise aerosol delivery of medications is critical for patient safety and treatment efficacy. The device’s role in these areas is supported by its classification as a compressed air nebulizer compressor (Product Code: CAF), which aligns with its intended use for inhalation therapy.

• Is the CPI Model 6240 50 PSI Nebulizer Compressor a single-use or reusable device, and what maintenance does it require?

  The CPI Model 6240 is a reusable medical instrument, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. Since it is not sterile out-of-the-box, regular cleaning and maintenance are essential to prevent contamination and ensure reliable performance. The manufacturer emphasizes adherence to these procedures to maintain functionality and safety in environments like operating rooms or recovery areas.

• What pressure does the CPI Model 6240 50 PSI Nebulizer Compressor operate at, and why is this specification important?

  The device operates at a consistent airflow pressure of 50 PSI, which is critical for delivering aerosolized medications effectively during inhalation therapy. This specification ensures reliable nebulization of liquid medications, making it suitable for precise clinical applications in anesthesia and respiratory care. Deviating from this pressure could compromise the device’s performance or safety.

• How was the CPI Model 6240 50 PSI Nebulizer Compressor evaluated by the FDA, and what does this mean for its regulatory status?

  The device received FDA 510(k) clearance (K964994) under the Traditional review pathway, with a decision date of February 21, 1997. This means the FDA determined it is substantially equivalent to a legally marketed predicate device, meeting safety and effectiveness requirements for its intended use in compressed air nebulization. The clearance was reviewed by the Anesthesiology (AN) Advisory Committee, reflecting its relevance to anesthesia and respiratory care environments.