Cleared Special

K011580 - SIMPLICITY SOFT QD SILVER INFUSION SET

K011580 is an FDA 510(k) clearance for SIMPLICITY SOFT QD SILVER INFUSION SET, 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.

K011580 · Sterling Medivations, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
14d
Days
Class 2
Risk

K011580 is an FDA 510(k) clearance for the SIMPLICITY SOFT QD SILVER INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Sterling Medivations, Inc. (Wayzata, US). The FDA issued a Cleared decision on June 5, 2001 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 - K011580

510(k) Number K011580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2001
Decision Date June 05, 2001
Days to Decision 14 days
Submission Type Special
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
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 K011580.
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K010886 · Sterling Medivations, Inc. · Apr 2001
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K010788 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY WINGED QD INFUSION SET
K010676 · Sterling Medivations, Inc. · Apr 2001