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Pentax Bs-LL1

by Hoya Corporation

Ref 04961333227259Model See UDI-DI information for model names

Pentax Bs-LL1 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 4961333010304XU), cleared under FDA 510(k) K951199 on 10 Apr 1995 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333227259), withdrawn (EUDAMED), active (FDA 510(k)) as of 25 Oct 2026. 2 FDA recalls are linked to it.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 Withdrawn in European Union.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CE MDR, withdrawn 510(k)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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K951199

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4961333010304XU Basic UDI-DI 04961333227259UDI-DIDate31 Jul 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04961333227259 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK951199 Date10 Apr 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4961333010304XU registered 31 Jul 2026 Withdrawn
  • FDA 510(k) K951199 decided 10 Apr 1995 Active
  • FDA GUDID UDI-DI 04961333227259 listed 7 Apr 2017 Listed

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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K951199
  2. Recall initiated FDA recalls Z-2065-2016
  3. Recall initiated FDA recalls Z-2076-2016
  4. Listed FDA GUDID 04961333227259
  5. Registered EUDAMED 4961333010304XU

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
PENTAX LED Light Source BS-LL1 EUDAMED
Pentax GUDID
Generic name
Endoscopic light source unit, battery-powered
Device name
PENTAX LED Light Source
Model / reference
See UDI-DI information for model names EUDAMED
04961333227259 EUDAMED
BS-LL1 GUDID
Primary DI / UDI-DI
04961333227259
Basic UDI-DI
4961333010304XU
Direct marketing DI
04961333228942
FDA product code
EOQ
EMDN code
Z129004 Light sources
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
See UDI-DI information for model names
04961333227259
GUDID
BS-LL1
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04961333227259: EUDAMED states No, FDA GUDID states Yes.

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: Endoscopic light source unit, battery-powered

Cleared under the same submission (K951199)

and 5 more cleared under K951199

Similar devices in this category

Other devices filed under LIGHT SOURCES.

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)