Cleared Traditional

BD PhaSeal? Optima Connecting Set (C83-O); BD PhaSeal? Optima Spike Set (C180-O)

K250059 · Becton, Dickinson and Company · General Hospital

Sep 2025

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K250059 is an FDA 510(k) clearance for the BD PhaSeal? Optima Connecting Set (C83-O); BD PhaSeal? Optima Spike Set (C180-O), a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on September 12, 2025, 245 days after receiving the submission on January 10, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K250059 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2025
Decision Date	September 12, 2025
Days to Decision	245 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.