Cleared Traditional

K170706 - Equashield Closed System drug Transfer Device (CSTD) (FDA 510(k) Clearance)

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

K170706 · Equashield Medical , Ltd. · General Hospital
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Jul 2017
Decision
117d
Days
Class 2
Risk

K170706 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 Tefen, IL). The FDA issued a Cleared decision on July 3, 2017 after a review of 117 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K170706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2017
Decision Date July 03, 2017
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 128d · This submission: 117d
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
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