Cleared Special

K020990 - SIMPLICITY SOFT QD II INFUSION SET FOR ...

K020990 is an FDA 510(k) clearance for SIMPLICITY SOFT QD II INFUSION SET FOR ..., manufactured by Sterling Medivations, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 14-day FDA review.

K020990 · Sterling Medivations, Inc. · General Hospital
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Apr 2002
Decision
14d
Days
Class 2
Risk

K020990 is an FDA 510(k) clearance for the SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS IN.... 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 10, 2002 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sterling Medivations, Inc. devices

FDA 510(k) Submission Details - K020990

510(k) Number K020990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2002
Decision Date April 10, 2002
Days to Decision 14 days
Submission Type Special
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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K020990.
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K014062 · Sterling Medivations, Inc. · Jan 2002