RC Cornet, Model #44F50

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K983308 ↗

FDA Product Code

BWF

Device Class

Class II

Regulation

21 CFR Part 868.5690

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K972042 Active Cleared 5 Aug 1997

See all devices from Pari Holding Co. →

• What is the RC Cornet Model #44F50 used for?

  The RC Cornet Model #44F50 is a Positive Expiratory Pressure (PEP) device classified as a Spirometer, Therapeutic (incentive). It provides resistance during patient exhalation to help mobilize secretions and support airway clearance and lung exercise.

• Is the RC Cornet Model #44F50 a single-use or reusable device?

  The device data does not specify whether the RC Cornet Model #44F50 is single-use or reusable. For information on proper usage and disposal, please consult the manufacturer's instructions or contact Pari Holding Co. directly.

• What is the regulatory status of the RC Cornet Model #44F50?

  The RC Cornet Model #44F50 received FDA 510(k) clearance with K983308 on June 4, 1999. It is classified as Class II with special controls under product code BWF with regulation number 868.5690, intended for use in Anesthesiology.

• How is the RC Cornet Model #44F50 supplied?

  The device data does not specify how the RC Cornet Model #44F50 is supplied, including packaging quantities or sterility information. For specific supply details, please contact the manufacturer Pari Holding Co. or refer to the product packaging.