CAM-10 Portable Volume Ventilator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Cam-10 Pvv Portable Volume Ventilator

510(k) Number

K791033 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Nev-10 Negative Pressure Ventilator

  Class II

  FDA 510(k) K910947 Active Cleared 3 Jun 1991

• 6-415 Filter, Element, 170-C

  Class II

  FDA 510(k) K802925 Active Cleared 19 Dec 1980

• Portable Lifecare Ventilator Plv-100

  Class II

  FDA 510(k) K832467 Active Cleared 20 Oct 1983

• Respiraotr, CAM-10 RBL

  Class II

  FDA 510(k) K790605 Active Cleared 3 Jul 1979

• Cam-10 Respiratory Hose Assemblies

  Class I

  FDA 510(k) K801859 Active Cleared 9 Sep 1980

• Lifecare Remote Alarm #34-001

  Class II

  FDA 510(k) K862212 Active Cleared 23 Jun 1986

See all devices from Lifecare Services, Inc. →

• What clinical settings is the CAM-10 Portable Volume Ventilator primarily intended for use in, and why is this important for buyers or clinicians?

  The CAM-10 is designed for anesthesia and critical care environments, as indicated by its regulatory filing under the Anesthesiology advisory committee. This specialization ensures it meets the precise needs of controlled mechanical ventilation in operating rooms, intensive care units, and other high-acuity settings where respiratory support is critical. Buyers and clinicians should prioritize this device for facilities where continuous, regulated airflow and oxygenation are essential for patient stability during procedures or prolonged respiratory assistance.

• Is the CAM-10 Portable Volume Ventilator intended for single-use or reusable applications, and what does this mean for maintenance and cost?

  The CAM-10 is explicitly described as a reusable medical instrument, meaning it is not designed for one-time use. This classification implies that facilities will need to establish protocols for cleaning, disinfection, and maintenance between patient use, which can impact operational workflows and long-term costs. Reusability also suggests durability, but buyers should confirm manufacturer guidelines for reprocessing to ensure compliance with infection control standards.

• What regulatory pathway was followed for the CAM-10’s FDA clearance, and how does this affect its use in clinical practice?

  The CAM-10 received FDA 510(k) clearance under the classification of Class II (CBK), with a decision date of July 3, 1979. This traditional clearance pathway confirms the device was deemed substantially equivalent to a legally marketed predicate device at the time, ensuring it meets established safety and effectiveness standards. Clinicians and buyers can rely on this classification for confidence in its regulatory scrutiny, though they should always verify compliance with current FDA guidelines and institutional policies for facility-based ventilators.

• Are there any specific storage requirements or considerations mentioned for the CAM-10 Portable Volume Ventilator?

  The provided data does not specify any details about storage conditions (e.g., temperature, humidity, or environmental protection) for the CAM-10. However, as a reusable facility-based device, it is likely intended for storage in a clean, dry area to prevent contamination or damage. Buyers should consult the manufacturer’s instructions or maintenance manuals for guidance on optimal storage practices to ensure longevity and readiness for use in clinical settings.