Pentax Bronchofiberscope FB-19E

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

510(k) Number

K822844 ↗

FDA Product Code

EOQ

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from Pentax Precision Instrument Corp. →

• Is the Pentax Bronchofiberscope FB-19E designed for single-use or can it be reused in clinical settings?

  The Pentax Bronchofiberscope FB-19E is explicitly supplied as a reusable medical instrument. It requires proper cleaning, disinfection, and maintenance per the manufacturer’s guidelines to ensure safe, repeated use in clinical settings like hospitals and outpatient facilities. Unlike single-use devices, it must be processed between patients to prevent cross-contamination.

• What types of procedures is this device intended to support in respiratory medicine?

  The FB-19E is a flexible fiberscope designed for bronchoscopic examination, allowing visual access to the trachea, bronchi, and surrounding lung tissue. This enables both diagnostic evaluations (e.g., biopsy sampling, cytology) and therapeutic interventions (e.g., lesion removal, airway clearance) in respiratory care. Its flexibility aids navigation through complex airway anatomy.

• How should the FB-19E be stored to maintain its performance and longevity?

  Since the FB-19E is reusable, storage must follow the manufacturer’s instructions to preserve its condition. Typically, this involves drying thoroughly after cleaning/disinfection, storing in a clean, dry environment (e.g., a protective case), and avoiding exposure to extreme temperatures or humidity. Proper maintenance extends the device’s lifespan and ensures reliable performance during procedures.

• What distinguishes the regulatory pathway for this device, and how does it relate to its intended use?

  The FB-19E was cleared via the FDA 510(k) process (traditional pathway, K822844) and classified under the Ear, Nose, and Throat (ENT) advisory committee. This classification reflects its primary use in airway examinations, aligning with ENT-related diagnostic/therapeutic procedures. The ‘substantially equivalent’ decision indicates it meets FDA standards for safety and effectiveness compared to predicate devices, though it does not imply sterility claims.