Cleared Special

BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR (K140591) - 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
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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.

View all Becton, Dickinson & CO devices

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 129d · 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 33
Devices cleared under the same product code (ONB) and FDA review panel - the closest regulatory comparables to K140591.
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
K180574 · J & J Solutions, Inc. D/B/A/ Corvida Medical · Aug 2018
Diana Medication Transfer Set
K170110 · Icu Medical, Inc. · Aug 2018
NEOSHIELD
K172499 · JMS North America Corporation · Jun 2018
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
K130197 · Becton, Dickinson and Company · Feb 2013
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
K123213 · Becton, Dickinson & CO · Jan 2013