Cleared Abbreviated

K012330 - SIMPLICITY EURO QD INFUSION SET

K012330 is an FDA 510(k) clearance for SIMPLICITY EURO QD 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 18-day FDA review.

K012330 · Sterling Medivations, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
18d
Days
Class 2
Risk

K012330 is an FDA 510(k) clearance for the SIMPLICITY EURO QD INFUSION SET. 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 August 10, 2001 after a review of 18 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 - K012330

510(k) Number K012330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date August 10, 2001
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 K012330.
SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE
K013104 · Sterling Medivations, Inc. · Oct 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · Sterling Medivations, Inc. · Sep 2001
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · Northgate Technologies, Inc. · Aug 2001
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
K011187 · Sterling Medivations, Inc. · Jun 2001
SIMPLICITY SOFT QD SILVER INFUSION SET
K011580 · Sterling Medivations, Inc. · Jun 2001
SIMPLICITY WING INFUSION SET
K010886 · Sterling Medivations, Inc. · Apr 2001