Cleared Abbreviated

Chemfort CSTD

K192866 · Simplivia Healthcare , Ltd. · General Hospital

May 2020

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K192866 is an FDA 510(k) clearance for the Chemfort CSTD, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Simplivia Healthcare , Ltd. (Kiryat Shmona, IL). The FDA issued a Cleared decision on May 7, 2020, 213 days after receiving the submission on October 7, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K192866 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 2019
Decision Date	May 07, 2020
Days to Decision	213 days
Submission Type	Abbreviated
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.