Cleared Traditional

K133097 - E-Z LINK

K133097 is an FDA 510(k) clearance for E-Z LINK, manufactured by Duoject Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K133097 · Duoject Medical Systems, Inc. · General Hospital
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Mar 2014
Decision
164d
Days
Class 2
Risk

K133097 is an FDA 510(k) clearance for the E-Z LINK. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Duoject Medical Systems, Inc. (Bromont, Qc., CA). The FDA issued a Cleared decision on March 13, 2014 after a review of 164 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 Duoject Medical Systems, Inc. devices

FDA 510(k) Submission Details - K133097

510(k) Number K133097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date March 13, 2014
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
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 80
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K133097.
APEX Compounding System Transfer Set
K151423 · B.Braun Medical, Inc. · Feb 2016
Universal Spike
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VIAL-MATE Adaptor
K142600 · Baxter Healthcare Corporation · Nov 2014
ADD-VANTAGE ADDAPTOR
K133602 · Hospira, Inc. · Jan 2014
DUAL SPIKE TRANSFER DEVICE
K120150 · B.Braun Medical, Inc. · May 2012
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011