Cleared Abbreviated

K021005 - SIMPLICITY EASY ACCESS II INFUSION SET ...

K021005 is an FDA 510(k) clearance for SIMPLICITY EASY ACCESS II INFUSION SET ..., manufactured by Sterling Medivations, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 28-day FDA review.

K021005 · Sterling Medivations, Inc. · General Hospital
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Apr 2002
Decision
28d
Days
Class 2
Risk

K021005 is an FDA 510(k) clearance for the SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUID.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Sterling Medivations, Inc. (Los Altos Hills, US). The FDA issued a Cleared decision on April 25, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sterling Medivations, Inc. devices

FDA 510(k) Submission Details - K021005

510(k) Number K021005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2002
Decision Date April 25, 2002
Days to Decision 28 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Standards-based clearance path.

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 512
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K021005.
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K021487 · Sterling Medivations, Inc. · May 2002
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K021216 · Sterling Medivations, Inc. · May 2002
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
K013621 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2002
SIMPLICITY EASY SOFT INFUSION SET
K020912 · Sterling Medivations, Inc. · Apr 2002
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
K020990 · Sterling Medivations, Inc. · Apr 2002