Skip to content

Pentax Of-D3

by Hoya Corporation

Ref 04961333169047Model See UDI-DI information for model names

Pentax Of-D3 is a device classified as Class I in the EU and Class II in the US made by Hoya Corporation, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 4961333010505Y8), cleared under FDA 510(k) K850020 on 9 Jul 1985 and listed in FDA GUDID since 31 Jul 2023 (UDI-DI 04961333169047), withdrawn (EUDAMED), active (FDA 510(k)) as of 24 Oct 2026. One FDA recall is linked to it.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K850020

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4961333010505Y8 Basic UDI-DI 04961333169047UDI-DIDate31 Jul 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04961333169047 UDI-DI Date31 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK850020 Date9 Jul 1985DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4961333010505Y8 registered 31 Jul 2026 Withdrawn
  • FDA 510(k) K850020 decided 9 Jul 1985 Active
  • FDA GUDID UDI-DI 04961333169047 listed 31 Jul 2023 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

6 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 04961333169047
  6. Registered EUDAMED 4961333010505Y8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Eyeshield Of-D3 EUDAMED
Pentax GUDID
Generic name
Scope eyepiece attachment
Device name
Eyeshield
Model / reference
See UDI-DI information for model names EUDAMED
04961333169047 EUDAMED
OF-D3 GUDID
Primary DI / UDI-DI
04961333169047
Basic UDI-DI
4961333010505Y8
510(k) Number
FDA product code
FDS
EMDN code
G0380 Digestive endoscopy devices - accessories
GMDN term
Scope eyepiece attachment
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
See UDI-DI information for model names
04961333169047
GUDID
OF-D3
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Scope eyepiece attachment

Cleared under the same submission (K850020)

and 7 more cleared under K850020

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES.

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)