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Pentax Eb-1575K

by Hoya Corporation

Pentax Eb-1575K is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K131028 on 10 Apr 2014 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333226818), active as of 22 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

510(k) K131028

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333226818 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131028 Date10 Apr 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131028 decided 10 Apr 2014 Active
  • FDA GUDID UDI-DI 04961333226818 listed 7 Apr 2017 Listed

Recalls

6 recalls · FDA

    • Terminated Z-2875-2016 FDA Class II initiated 31 May 2016

    Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

  • 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.

  • 3 recalls, same reason

    • Terminated Z-2325-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2326-2017 FDA Class II initiated 11 Jan 2011
    • Terminated Z-2324-2017 FDA Class II initiated 11 Jan 2011

    This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

Timeline

8 dated events

  1. Recall initiated FDA recalls Z-2325-2017
  2. Recall initiated FDA recalls Z-2326-2017
  3. Recall initiated FDA recalls Z-2324-2017
  4. Cleared FDA 510(k) K131028
  5. Recall initiated FDA recalls Z-2065-2016
  6. Recall initiated FDA recalls Z-2076-2016
  7. Recall initiated FDA recalls Z-2875-2016
  8. Listed FDA GUDID 04961333226818

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pentax
Generic name
Flexible video bronchoscope, reusable
Model / reference
EB-1575K
Primary DI / UDI-DI
04961333226818
FDA product code
EOQ
GMDN term
Flexible video bronchoscope, reusable
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Flexible video bronchoscope, reusable

Cleared under the same submission (K131028)

and 8 more cleared under K131028

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)