Cleared Traditional

K083152 - EQUASHIELD SYSTEM

K083152 is an FDA 510(k) clearance for EQUASHIELD SYSTEM, manufactured by Plastmed, Ltd.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K083152 · Plastmed, Ltd. · General Hospital
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Feb 2009
Decision
101d
Days
Class 2
Risk

K083152 is an FDA 510(k) clearance for the EQUASHIELD SYSTEM. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Plastmed, Ltd. (Tefen Industrial Park, IL). The FDA issued a Cleared decision on February 2, 2009 after a review of 101 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 Plastmed, Ltd. devices

FDA 510(k) Submission Details - K083152

510(k) Number K083152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2008
Decision Date February 02, 2009
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 94
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K083152.
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
K092246 · Nipro Medical Corporation · Nov 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · Baxter Healthcare Corporation · Oct 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009
NEXUS I.V. FLUID TRANSFER DEVICE
K080976 · Nexus Medical, LLC · Nov 2008
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · B.Braun Medical, Inc. · Oct 2004
BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004