Cleared Traditional

K111924 - FINESSE PERSONAL INSULIN DELIVERY PATCH

K111924 is an FDA 510(k) clearance for FINESSE PERSONAL INSULIN DELIVERY PATCH, manufactured by Calibra Medical, Inc.. The device is a Class 2 General Hospital device with product code OPP cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K111924 · Calibra Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
279d
Days
Class 2
Risk

K111924 is an FDA 510(k) clearance for the FINESSE PERSONAL INSULIN DELIVERY PATCH. Classified as Pump, Infusion, Insulin Bolus (product code OPP), Class II - Special Controls.

Submitted by Calibra Medical, Inc. (Redwood City, US). The FDA issued a Cleared decision on April 10, 2012 after a review of 279 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K111924

510(k) Number K111924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2011
Decision Date April 10, 2012
Days to Decision 279 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
150d slower than avg
Panel avg: 129d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

OPP Device Classification - Class 2, Special Controls

Product Code OPP Pump, Infusion, Insulin Bolus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition The Device Is Adhered To The Body For Several Days For The Purpose Of Periodically Infusing An Insulin Bolus.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General Hospital devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01073566 Completed Interventional Industry-sponsored

Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections

The Effects of Finesse on Glycemic Control in Adults With Diabetes Using MDI: Finesse vs. Pen or Syringe and Vial as Bolus Prandial Insulin Device

38
Patients (actual)
5
Sites
Treatment
Purpose
Open label
Masking
Condition studied Diabetes Mellitus
Study design Crossover
Eligibility All sexes · 18 Years+
Principal investigator Vice President Clinical Affairs
Sponsor Calibra Medical, Inc. (industry)
Started 2010-01-01 → Primary completion 2010-07-01
Primary outcome
Mean Daily Blood Glucose
Secondary outcome
Glucose Profiles Per Day
View full study on ClinicalTrials.gov

Regulatory Peers - OPP Pump, Infusion, Insulin Bolus

Devices cleared under the same product code (OPP) and FDA review panel - the closest regulatory comparables to K111924.
CeQur Simplicity™ On-Demand Insulin Delivery System
K243273 · Cequr SA · Nov 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447 · Cequr SA · Jan 2024
OneTouch Via On-Demand Insulin Delivery System
K163357 · Lifescan Europe, A Division of Cilag GmbH · Jun 2017
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
K100947 · Calibra Medical, Inc. · Jun 2010
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
K093065 · Calibra Medical, Inc. · Jan 2010
K111924 · FINESSE PERSONAL INSULIN DELIVERY PATCH
Download PDF FDA Summary Calibra Medical, Inc.