Cleared Traditional

K013767 - SIMPLICITY INFUSION RESERVOIR FOR USE T...

K013767 is an FDA 510(k) clearance for SIMPLICITY INFUSION RESERVOIR FOR USE T..., manufactured by Sterling Medivations, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K013767 · Sterling Medivations, Inc. · General Hospital
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Dec 2001
Decision
29d
Days
Class 2
Risk

K013767 is an FDA 510(k) clearance for the SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, .... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sterling Medivations, Inc. (Los Altos Hills, US). The FDA issued a Cleared decision on December 12, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sterling Medivations, Inc. devices

FDA 510(k) Submission Details - K013767

510(k) Number K013767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date December 12, 2001
Days to Decision 29 days
Submission Type Traditional
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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 454
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K013767.
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