Cleared Traditional

K173477 - ChemoCLAVE Cytotoxic Medication Prepara...

K173477 is the FDA 510(k) clearance for ChemoCLAVE Cytotoxic Medication Prepara... by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code ONB) cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K173477 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
291d
Days
Class 2
Risk

K173477 is an FDA 510(k) clearance for the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System. Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 31, 2018 after a review of 291 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Icu Medical, Inc. devices

Submission Details

510(k) Number K173477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date August 31, 2018
Days to Decision 291 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 129d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

All 34
Devices cleared under the same product code (ONB) and FDA review panel - the closest regulatory comparables to K173477.
Diana ChemoClave Transfer Set
K190157 · Icu Medical · Oct 2019
BD PhaSeal Optima Closed System Transfer Device
K181221 · Becton, Dickinson and Company · Nov 2018
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K180489 · Teva Medical Ltd., Migada Plant · Sep 2018
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
K180574 · J & J Solutions, Inc. D/B/A/ Corvida Medical · Aug 2018
Diana Medication Transfer Set
K170110 · Icu Medical, Inc. · Aug 2018
NEOSHIELD
K172499 · JMS North America Corporation · Jun 2018