Cleared Abbreviated

K010846 - SIMPLICITY SILVER SET SOFT INFUSION

K010846 is an FDA 510(k) clearance for SIMPLICITY SILVER SET SOFT INFUSION, 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 22-day FDA review.

K010846 · Sterling Medivations, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
22d
Days
Class 2
Risk

K010846 is an FDA 510(k) clearance for the SIMPLICITY SILVER SET SOFT INFUSION. 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 April 12, 2001 after a review of 22 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 - K010846

510(k) Number K010846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2001
Decision Date April 12, 2001
Days to Decision 22 days
Submission Type Abbreviated
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
107d faster than avg
Panel avg: 129d · This submission: 22d
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 K010846.
SIMPLICITY SOFT QD EASY INFUSION SET
K010788 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY WINGED QD INFUSION SET
K010676 · Sterling Medivations, Inc. · Apr 2001
SIMPLICITY INFUSER INFUSION SET
K010647 · Sterling Medivations, Inc. · Apr 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
K010373 · Sterling Medivations, Inc. · Mar 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · Quest Medical, Inc. · Mar 2001