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Pump Remote Cable Maj-920

by Olympus Medical Systems Corporation

Pump Remote Cable Maj-920 (6860500) is a Class II device made by Olympus Medical Systems Corporation, cleared under FDA 510(k) K222861 on 15 Jun 2023 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04953170026492), active as of 23 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

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222861 Date15 Jun 2023DecidedStatusActive
United StatesGUDID listing Number04953170026492 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222861 decided 15 Jun 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04953170026492 listed 21 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0181-2025 FDA Class II initiated 21 Aug 2024

    It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

Timeline

4 dated events

  1. Listed FDA GUDID 04953170026492
  2. Cleared FDA 510(k) K222584
  3. Cleared FDA 510(k) K222861
  4. Recall initiated FDA recalls Z-0181-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pump Remote Cable
Generic name
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
MAJ-920, 6860500
Primary DI / UDI-DI
04953170026492
510(k) Number
FDA product code
EOQ, EOB, FDF, FDS, NWB, FET, NTN
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class II
Regulation number
874.4680, 874.4760, 876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K222584)

and 3 more cleared under K222584

Cleared under the same submission (K222861)

Similar devices in this category

Other devices filed under Electrical-only medical device connection cable, reusable.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

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