Cleared Traditional

Diana Medication Transfer Set

K170110 · Icu Medical, Inc. · General Hospital

Aug 2018

Decision

575d

Days

Class 2

Risk

About This 510(k) Submission

K170110 is an FDA 510(k) clearance for the Diana Medication Transfer Set, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 10, 2018, 575 days after receiving the submission on January 12, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K170110 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2017
Decision Date	August 10, 2018
Days to Decision	575 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting.