Cleared Traditional

OnGuard2 Chemfort Closed Administration (CADM)

K210707 · Simplivia Healthcare , Ltd. · General Hospital

Sep 2021

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K210707 is an FDA 510(k) clearance for the OnGuard2 Chemfort Closed Administration (CADM), 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 September 23, 2021, 197 days after receiving the submission on March 10, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K210707 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2021
Decision Date	September 23, 2021
Days to Decision	197 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.