Cleared Traditional

Chemfort? Catheter Adaptor

K231286 · Simplivia Healthcare , Ltd. · General Hospital

Aug 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K231286 is an FDA 510(k) clearance for the Chemfort? Catheter Adaptor, 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 August 2, 2023, 90 days after receiving the submission on May 4, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K231286 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2023
Decision Date	August 02, 2023
Days to Decision	90 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.