Cleared Abbreviated

K010373 - SIMPLICITY SOFT Y INFUSION SET FOR USE ...

K010373 is an FDA 510(k) clearance for SIMPLICITY SOFT Y INFUSION SET FOR USE ..., 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 34-day FDA review.

K010373 · Sterling Medivations, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
34d
Days
Class 2
Risk

K010373 is an FDA 510(k) clearance for the SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MI.... 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 March 13, 2001 after a review of 34 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 - K010373

510(k) Number K010373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2001
Decision Date March 13, 2001
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 K010373.
SIMPLICITY INFUSER INFUSION SET
K010647 · Sterling Medivations, Inc. · Apr 2001
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K010846 · Sterling Medivations, Inc. · Apr 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · Quest Medical, Inc. · Mar 2001
TAXOL ADMINISTRATION SET
K003513 · Icu Medical, Inc. · Jan 2001
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K003283 · Sterling Medivations, Inc. · Dec 2000