Model 2500 Pneumatic Percussor

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

510(k) Number

K802399 ↗

FDA Product Code

BYI

Device Class

Class II

Regulation

21 CFR Part 868.5665

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Modified Memory Retractor Arm

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  FDA 510(k) K874833 Active Cleared 3 Mar 1988

• Med-Tech Radiolucent Head Fixation System

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• What is the Model 2500 Pneumatic Percussor used for?

  The Model 2500 Pneumatic Percussor is designed to assist with airway clearance therapy by generating rhythmic chest wall vibrations. These vibrations help mobilize lung secretions, making it easier for patients with respiratory conditions—such as chronic bronchitis or cystic fibrosis—to clear mucus and improve breathing.

• Is the Model 2500 Pneumatic Percussor reusable or single-use?

  The Model 2500 Pneumatic Percussor is supplied as a reusable device. While it does not require sterile packaging, it must be cleaned and maintained according to standard medical device protocols to ensure safe, repeated clinical use.

• What regulatory approval does the Model 2500 Pneumatic Percussor hold?

  The device holds FDA 510(k) clearance (K802399) under regulation number 868.5665, classified as a Class II medical device. This clearance confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. safety and performance standards.

• Are there specific storage instructions for the Model 2500 Pneumatic Percussor?

  The available data does not specify any special storage requirements beyond general medical device maintenance. It is recommended to store the device in a clean, dry environment, protected from moisture and physical damage, to preserve its functionality for clinical use.

• Can the Model 2500 Pneumatic Percussor be used in MRI environments?

  The documentation does not provide explicit MRI safety information for the Model 2500 Pneumatic Percussor. Clinicians should verify compatibility with their MRI facility’s guidelines before use, as electromagnetic interference or metallic components could pose risks in magnetic environments.