Cleared Traditional

K151079 - Q2 Intravenous Adminstration Sets and E...

K151079 is the FDA 510(k) clearance for Q2 Intravenous Adminstration Sets and E... by Quest Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K151079 · Quest Medical, Inc. · General Hospital
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Sep 2015
Decision
161d
Days
Class 2
Risk

K151079 is an FDA 510(k) clearance for the Q2 Intravenous Adminstration Sets and Extension Sets. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on September 30, 2015 after a review of 161 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 Quest Medical, Inc. devices

Submission Details

510(k) Number K151079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2015
Decision Date September 30, 2015
Days to Decision 161 days
Submission Type Traditional
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
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 448
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K151079.
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K153158 · Baxter Healthcare Corporation · Dec 2015
BD FlowSmart Set, MiniMed Pro-Set
K153257 · Becton, Dickinson and Company · Dec 2015
IV Administration Sets with 200(micro)m Blood Filter
K143082 · B.Braun Medical, Inc. · Jul 2015
Nitroglycerin Sets with DUO-VENT Spike
K150860 · Baxter Healthcare Corporation · Apr 2015
Hospira Blood Set
K143087 · Hospira, Inc. · Mar 2015