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Medex MX20816

by ICU Medical, Inc.

Medex MX20816 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K790314 on 6 Mar 1979 and listed in FDA GUDID since 19 Oct 2016 (UDI-DI 10351688508836), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K790314

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 Number10351688508836 UDI-DI Date19 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK790314 Date6 Mar 1979DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K790314 decided 6 Mar 1979 Active
  • FDA GUDID UDI-DI 10351688508836 listed 19 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1549-2008 FDA Unclassified (pre-2012) initiated 24 Mar 2008 on shared 510(k) K790314

    Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K790314
  2. Recall initiated FDA recalls Z-1549-2008
  3. Listed FDA GUDID 10351688508836

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  • Withdrawn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
Basic intravenous administration set, noninvasive
Model / reference
MX20816
Primary DI / UDI-DI
10351688508836
510(k) Number
FDA product code
FPB
GMDN term
Basic intravenous administration set, noninvasive
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Basic intravenous administration set, noninvasive

Cleared under the same submission (K790314)

and 8 more cleared under K790314

Similar devices in this category

Other devices filed under Basic intravenous administration set, noninvasive.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)