Cleared Traditional

K012879 - EXEL HUBER INFUSION SET WITH NEEDLELESS...

K012879 is an FDA 510(k) clearance for EXEL HUBER INFUSION SET WITH NEEDLELESS..., manufactured by Exelint Intl. Co.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K012879 · Exelint Intl. Co. · General Hospital
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Jan 2002
Decision
142d
Days
Class 2
Risk

K012879 is an FDA 510(k) clearance for the EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Exelint Intl. Co. (Los Angeles, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 142 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 Exelint Intl. Co. devices

FDA 510(k) Submission Details - K012879

510(k) Number K012879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2001
Decision Date January 17, 2002
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 513
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K012879.
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K020990 · Sterling Medivations, Inc. · Apr 2002
SIMPLICITY SIMPLEX SOFT INFUSION SET
K020629 · Sterling Medivations, Inc. · Apr 2002
SIMPLICITY STARPLUS SOFT INFUSION SET
K014061 · Sterling Medivations, Inc. · Jan 2002
SIMPLICITY EASY ACCESS INFUSION SET
K014062 · Sterling Medivations, Inc. · Jan 2002
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502 · Sterling Medivations, Inc. · Dec 2001