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Pentax Al-OR3

by Hoya Corporation

Pentax Al-OR3 is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K850020 on 9 Jul 1985 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333118380), active as of 22 Oct 2026. One FDA recall is 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

3 closed

Documents

510(k) K850020

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 Number04961333118380 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK850020 Date9 Jul 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K850020 decided 9 Jul 1985 Active
  • FDA GUDID UDI-DI 04961333118380 listed 7 Apr 2017 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2071-2016 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.

    • Terminated Z-2290-2014 FDA Class II initiated 17 Jul 2014 on shared 510(k) K850020

    The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

    • Terminated Z-0084-2014 FDA Class I initiated 16 Sep 2013 on shared 510(k) K850020

    PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K850020
  2. Recall initiated FDA recalls Z-0084-2014
  3. Recall initiated FDA recalls Z-2290-2014
  4. Recall initiated FDA recalls Z-2071-2016
  5. Listed FDA GUDID 04961333118380

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  • Withdrawn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
Light source adaptor
Model / reference
AL-OR3
Primary DI / UDI-DI
04961333118380
510(k) Number
FDA product code
FDS
GMDN term
Light source adaptor
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Light source adaptor

Cleared under the same submission (K850020)

and 7 more cleared under K850020

Similar devices in this category

Other devices filed under Light source adaptor.

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)