Cleared Special

K140591 - BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K140591 · Becton, Dickinson & CO · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
68d
Days
Class 2
Risk

K140591 is an FDA 510(k) clearance for the BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR. Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on May 14, 2014 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K140591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2014
Decision Date May 14, 2014
Days to Decision 68 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 128d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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
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