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Medex M20178R2

by ICU Medical, Inc.

Medex M20178R2 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K820355 on 4 Mar 1982 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10351688510785), 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

510(k) K820355

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10351688510785 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK820355 Date4 Mar 1982DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K820355 decided 4 Mar 1982 Active
  • FDA GUDID UDI-DI 10351688510785 listed 11 Oct 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0739-2024 FDA Class II initiated 10 Nov 2023

    There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Timeline

3 dated events

  1. Cleared FDA 510(k) K820355
  2. Listed FDA GUDID 10351688510785
  3. Recall initiated FDA recalls Z-0739-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medex
Generic name
Angiography kit
Model / reference
M20178R2
Primary DI / UDI-DI
10351688510785
510(k) Number
FDA product code
DRS
GMDN term
Angiography kit
Device class
Class II
Regulation number
870.2850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Angiography kit

Cleared under the same submission (K820355)

and 8 more cleared under K820355

Similar devices in this category

Other devices filed under Angiography kit.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)