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Diana Medication Transfer Set

by ICU Medical, Inc.

510(k) K170110

Diana Medication Transfer Set is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K170110 on 10 Aug 2018, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

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 FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170110 Date10 Aug 2018ClearedStatusActive

Official records

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

2 dated events

  1. Cleared FDA 510(k) K170110
  2. 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  • Withdrawn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

510(k)

510(k) Number
FDA product code
ONB
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K170110

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K170110
UDI-DISize and differences
ICU Medical CL6000
ICU MEDICAL, INC.
CL6000 / CL600000887709090514 —On the market
ICU Medical CL6000-5
ICU MEDICAL, INC.
CL6000-5 / CL6000-500887709099166 —On the market

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. →