Cleared Special

K100947 - FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000

K100947 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 Special 510(k) pathway after a 83-day FDA review.

K100947 · Calibra Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
83d
Days
Class 2
Risk

K100947 is an FDA 510(k) clearance for the FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000. 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 June 28, 2010 after a review of 83 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100947

510(k) Number K100947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2010
Decision Date June 28, 2010
Days to Decision 83 days
Submission Type Special
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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

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. 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 - OPP Pump, Infusion, Insulin Bolus

Devices cleared under the same product code (OPP) and FDA review panel - the closest regulatory comparables to K100947.
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
K111924 · Calibra Medical, Inc. · Apr 2012
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
K093065 · Calibra Medical, Inc. · Jan 2010
K100947 · FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
Download PDF FDA Summary Calibra Medical, Inc.