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ICU Medical CL6000

by ICU Medical, Inc.

ICU Medical CL6000 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K170110 on 10 Aug 2018 and listed in FDA GUDID since 29 Aug 2021 (UDI-DI 00887709090514), active as of 22 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) K170110

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 Number00887709090514 UDI-DI Date29 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170110 Date10 Aug 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170110 decided 10 Aug 2018 Active
  • FDA GUDID UDI-DI 00887709090514 listed 29 Aug 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3161-2026 FDA Class II initiated 12 May 2026

    Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Timeline

3 dated events

  1. Cleared FDA 510(k) K170110
  2. Listed FDA GUDID 00887709090514
  3. Recall initiated FDA recalls Z-3161-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ICU Medical
Generic name
Compounding transfer set
Model / Ref / Catalog
CL6000
Primary DI / UDI-DI
00887709090514
510(k) Number
FDA product code
ONB
GMDN term
Compounding transfer set
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Compounding transfer set

Cleared under the same submission (K170110)

Similar devices

Other devices filed under FDA product code ONB (Closed antineoplastic and hazardous drug reconstitution and transfer system).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

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