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Pentax Os-A43

by Hoya Corporation

Pentax Os-A43 is a Class II device made by Hoya Corporation, cleared under FDA 510(k) K231249 on 28 Jul 2023 and listed in FDA GUDID since 15 Sep 2023 (UDI-DI 04961333075157), active as of 22 Oct 2026. 4 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

4 ongoing

This device is named in the recall

Documents

510(k) K231249

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 Number04961333075157 UDI-DI Date15 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231249 Date28 Jul 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231249 decided 28 Jul 2023 Active
  • FDA GUDID UDI-DI 04961333075157 listed 15 Sep 2023 Listed

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-2329-2025 FDA Class II initiated 16 Jul 2025

    During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.

  • 3 recalls, same reason

    • Ongoing Z-1237-2025 FDA Class II initiated 29 Jan 2025
    • Ongoing Z-1236-2025 FDA Class II initiated 29 Jan 2025
    • Ongoing Z-1238-2025 FDA Class II initiated 29 Jan 2025

    During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

Timeline

6 dated events

  1. Cleared FDA 510(k) K231249
  2. Listed FDA GUDID 04961333075157
  3. Recall initiated FDA recalls Z-1237-2025
  4. Recall initiated FDA recalls Z-1236-2025
  5. Recall initiated FDA recalls Z-1238-2025
  6. Recall initiated FDA recalls Z-2329-2025

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
Endoscope calibration cover, reusable
Model / reference
OS-A43
Primary DI / UDI-DI
04961333075157
FDA product code
PEA, FDS, FDF
GMDN term
Endoscope calibration cover, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Endoscope calibration cover, reusable

Cleared under the same submission (K231249)

Similar devices

Other devices filed under FDA product code PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement).

Other devices from Hoya Corporation

See all devices from Hoya Corporation →

Properties

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