Respiraotr, CAM-10 RBL

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790605 ↗

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

• 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

• Cam-10 Exsufflation Belt #11-001

  Class II

  FDA 510(k) K800999 Active Cleared 28 May 1980

See all devices from Lifecare Services, Inc. →

• What is the RESPIRAOTR CAM-10 RBL used for?

  The RESPIRAOTR CAM-10 RBL is a ventilator designed for continuous use in facility settings, specifically intended for anesthesiology applications. It is classified as a Class II medical device under product code CBK with special controls.

• How is the RESPIRAOTR CAM-10 RBL supplied and what are its storage requirements?

  The device is supplied for facility use and requires appropriate storage conditions to maintain its functionality. The manufacturer is Lifecare Services, Inc., and the device should be stored according to the manufacturer's specifications to ensure proper performance.

• What is the regulatory status of the RESPIRAOTR CAM-10 RBL?

  The RESPIRAOTR CAM-10 RBL was cleared by the FDA on July 3, 1979 under 510(k) number K790605. It is regulated under 868.5895 and is classified as a Class II medical device with special controls.

• Is the RESPIRAOTR CAM-10 RBL reusable or single-use?

  The device is designed for continuous use in facility settings, indicating it is intended for reuse rather than single-use. However, specific reprocessing instructions would be provided by the manufacturer to ensure proper maintenance and safety.