Cleared Traditional

K150219 - Equashield Closed System drug Transfer Device (CSTD)

K150219 is an FDA 510(k) clearance for Equashield Closed System drug Transfer ..., manufactured by Equashield Medical , Ltd.. The device is a Class 2 General Hospital device with product code ONB cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K150219 · Equashield Medical , Ltd. · General Hospital
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Nov 2015
Decision
279d
Days
Class 2
Risk

K150219 is an FDA 510(k) clearance for the Equashield Closed System drug Transfer Device (CSTD). Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Equashield Medical , Ltd. (Migdal, IL). The FDA issued a Cleared decision on November 5, 2015 after a review of 279 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 Equashield Medical , Ltd. devices

FDA 510(k) Submission Details - K150219

510(k) Number K150219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2015
Decision Date November 05, 2015
Days to Decision 279 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 129d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONB Device Classification - Class 2, Special Controls

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 Consultant

Licensale, Inc.
Raymond J Kelly IV

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K150219.
NEOSHIELD
K172499 · JMS North America Corporation · Jun 2018
Equashield Closed System drug Transfer Device (CSTD)
K170706 · Equashield Medical , Ltd. · Jul 2017
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K170680 · Teva Medical Ltd., Migada Plant · May 2017
Halo
K150486 · J & J Solutions, Inc. D/B/A/ Corvida Medical · Jul 2015
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K141448 · Teva Medical Ltd., Migada Plant · Jan 2015
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
K140591 · Becton, Dickinson & CO · May 2014