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Medivators Hookup

by Medivators Inc. 365 variants

Medivators Hookup (28040) is a Class II device made by Medivators Inc., cleared under FDA 510(k) K172677 on 19 Dec 2017 (1 earlier submission) and listed in FDA GUDID since 10 Apr 2023 (UDI-DI 00677964072284), active as of 31 May 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

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00677964072284 UDI-DI Date10 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172677 Date19 Dec 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172677 decided 19 Dec 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00677964072284 listed 10 Apr 2023 Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2538-2024 FDA Class II initiated 13 Jun 2024
    • Ongoing Z-2536-2024 FDA Class II initiated 13 Jun 2024
    • Ongoing Z-2537-2024 FDA Class II initiated 13 Jun 2024

    IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection

    • Ongoing Z-0617-2024 FDA Class II initiated 13 Nov 2023

    Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of patient procedures.

Timeline

7 dated events

  1. Cleared FDA 510(k) K102996
  2. Cleared FDA 510(k) K172677
  3. Listed FDA GUDID 00677964072284
  4. Recall initiated FDA recalls Z-0617-2024
  5. Recall initiated FDA recalls Z-2538-2024
  6. Recall initiated FDA recalls Z-2536-2024
  7. Recall initiated FDA recalls Z-2537-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Luminal device flushing tubing set, reusable
Model / Ref / Catalog
Hookup, 28040
Primary DI / UDI-DI
00677964072284
510(k) Number
FDA product code
FEB
GMDN term
Luminal device flushing tubing set, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Luminal device flushing tubing set, reusable

Cleared under the same submission (K102996)

and 8 more cleared under K102996

Cleared under the same submission (K172677)

and 8 more cleared under K172677

Similar devices in this category

Other devices filed under Luminal device flushing tubing set, reusable.

Other devices from Medivators Inc.

See all devices from Medivators Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)