Cleared Traditional

K250059 - BD PhaSeal™ Optima Connecting Set (C83-O) (FDA 510(k) Clearance)

Also includes:
BD PhaSeal™ Optima Spike Set (C180-O)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250059 · Becton, Dickinson and Company · General Hospital
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Sep 2025
Decision
245d
Days
Class 2
Risk

K250059 is an FDA 510(k) clearance for the BD PhaSeal™ Optima Connecting Set (C83-O). Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on September 12, 2025 after a review of 245 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton, Dickinson and Company devices

Submission Details

510(k) Number K250059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 128d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

All 40
Devices cleared under the same product code (ONB) and FDA review panel - the closest regulatory comparables to K250059.
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K251340 · Epic Medical Pte. , Ltd. · May 2025
ZeroClear™ Bag Access (423100)
K243976 · Epic Medical Pte. , Ltd. · Jan 2025
ProSeal™ Vented Universal Vial Adaptor
K240517 · Epic Medical Pte. , Ltd. · Dec 2024