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FB-18X Fiber Bronchoscope

by Pentax Precision Instrument Corp.

510(k) K951199

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951199 Date10 Apr 1995ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2065-2016 FDA Class II initiated 6 Apr 2016
    • Terminated Z-2076-2016 FDA Class II initiated 6 Apr 2016

    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EOQ
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FB-18X Fiber Bronchoscope is a fiberoptic bronchoscope intended for diagnostic and therapeutic procedures of the respiratory tract in hospital and clinic settings. It provides a detailed visual examination of the airways through a flexible insertion tube equipped with optical fibers.

The device is supplied with a 6.0 mm diameter insertion tube, a 2.2 mm instrument channel and a 600 mm working length. It has received FDA 510(k) clearance (K951199) under product code EOQ and is listed as a traditional clearance type.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical procedures is the FB-18X designed for?

    The FB-18X is intended for both diagnostic and therapeutic procedures within the respiratory tract, allowing clinicians to visually inspect and intervene in the airways of patients in hospital or clinic settings.

  • What are the key dimensions of the FB-18X insertion tube?

    The bronchoscope features a 6.0 mm diameter insertion tube, a 2.2 mm instrument channel for accessories, and a 600 mm working length, providing sufficient reach and maneuverability for airway examinations.

  • How is the FB-18X supplied and is it reusable?

    The device is supplied as a complete bronchoscope system with the specified tube and channel dimensions. It is a reusable fiberoptic instrument that must be reprocessed according to the manufacturer’s cleaning and sterilization guidelines before each use.

  • What regulatory pathway did the FB-18X follow?

    The FB-18X received FDA 510(k) clearance (K951199) under product code EOQ, classified as a traditional clearance type, indicating it was found substantially equivalent to a legally marketed predicate device.