Cleared Special

Chemfort? 28-day 20 mm Vial Adaptor and 13 mm Convertor

K253033 · Simplivia Healthcare , Ltd. · General Hospital

Oct 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K253033 is an FDA 510(k) clearance for the Chemfort? 28-day 20 mm Vial Adaptor and 13 mm Convertor, 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 October 21, 2025, 29 days after receiving the submission on September 22, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K253033 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2025
Decision Date	October 21, 2025
Days to Decision	29 days
Submission Type	Special
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.